Is phonophoresis effective in the treatment of chronic low back pain? A single-blind randomized...

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ORIGINAL ARTICLE Is phonophoresis effective in the treatment of chronic low back pain? A single-blind randomized controlled trial Dilek Durmus Gamze Alayli Ahmet Salim Goktepe Mehmet Ali Taskaynatan Ayhan Bilgici Omer Kuru Received: 18 March 2012 / Accepted: 15 December 2012 Ó Springer-Verlag Berlin Heidelberg 2012 Abstract The aim of this trial is to investigate and compare the effects of phonophoresis (PP) and ultrasound (US) therapy on pain, disability, trunk muscle strength, walking performance, spinal mobility, quality of life (QOL), and depression in the patients with chronic low back pain (CLBP). A total of 60 patients with definite CLBP were included in this study. The patients were ran- domized into three groups. Group 1 (n = 20) was accepted as the control group and was given only exercises. Group 2 (n = 20) received US treatment and exercises. Group 3 (n = 20) received PP and exercises. All of the programs were performed 3 days a week, for 6 weeks. The pain (visual analog scale, VAS), disability (Oswestry Disability Questionnaire, ODQ and pain disability index, PDI), walking performance (6 min walking test, 6MWT), depression (Beck Depression Inventory scores, BDI), and QOL (Short Form 36, SF-36) of all participants were evaluated. The trunk muscle strength was measured with a handheld dynamometer. All of the groups showed statisti- cally significant improvements in pain, disability, muscle strength, endurance, 6MWT, mobility, QOL, and depres- sion. The intergroup comparison showed significant dif- ferences in VAS pain, 6MWT, and EMS, among three groups. These differences were statistically significant in groups 2 and 3 compared with the group 1. The intergroup comparison showed significant difference in pain, physical function, and energy subgroups of SF-36. The differences were statistically in group 3 compared with group 1 and 2. We observed that US and PP treatments were effective in the treatment of patients with CLBP but PP was not found to be superior over ultrasound therapy. Keywords Chronic low back pain Á Phonophoresis Á Ultrasound Á Trunk muscle strength Á Pain Á Disability Á Endurance Á Quality of life Á Depression Introduction Chronic low back pain (CLBP) is a severe health problem, especially in industrial areas due to its high prevalence and frequent association with disability [1]. Low back pain affects 50–80 % of adults at some time during their lives, and it appears to be an important medical condition with its consequences. The CLBP gives rise to physical and psy- chological problems, disability, and deterioration in the quality of life (QOL) [2]. Chronic low back pain has been found to be associated with certain postural, muscular, and mobility characteris- tics. Numerous etiologic factors have been linked with the condition: Increased lumbar lordosis, decreased abdominal muscle strength, imbalance between flexor and extensor trunk muscle strength, reduced spinal mobility. Trunk muscle strength has been extensively studied in relation to CLBP. Most of the researchers have found trunk muscle strength to be an important factor in CLBP [3]. There are various approaches involved in the treatment of the CLBP. Exercise and stretching have been established as wellness-focused coping strategies in the management of CLBP. Along with supervised exercise, they have D. Durmus (&) Á G. Alayli Á A. Bilgici Á O. Kuru Department of Physical Medicine and Rehabilitation, Medical Faculty, Ondokuz Mayis University, Samsun, Turkey e-mail: [email protected] A. S. Goktepe Á M. A. Taskaynatan Gulhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Rehabilitation Hospital, Bilkent, Ankara, Turkey 123 Rheumatol Int DOI 10.1007/s00296-012-2634-7

Transcript of Is phonophoresis effective in the treatment of chronic low back pain? A single-blind randomized...

Page 1: Is phonophoresis effective in the treatment of chronic low back pain? A single-blind randomized controlled trial

ORIGINAL ARTICLE

Is phonophoresis effective in the treatment of chronic low backpain? A single-blind randomized controlled trial

Dilek Durmus • Gamze Alayli • Ahmet Salim Goktepe •

Mehmet Ali Taskaynatan • Ayhan Bilgici •

Omer Kuru

Received: 18 March 2012 / Accepted: 15 December 2012

� Springer-Verlag Berlin Heidelberg 2012

Abstract The aim of this trial is to investigate and

compare the effects of phonophoresis (PP) and ultrasound

(US) therapy on pain, disability, trunk muscle strength,

walking performance, spinal mobility, quality of life

(QOL), and depression in the patients with chronic low

back pain (CLBP). A total of 60 patients with definite

CLBP were included in this study. The patients were ran-

domized into three groups. Group 1 (n = 20) was accepted

as the control group and was given only exercises. Group 2

(n = 20) received US treatment and exercises. Group 3

(n = 20) received PP and exercises. All of the programs

were performed 3 days a week, for 6 weeks. The pain

(visual analog scale, VAS), disability (Oswestry Disability

Questionnaire, ODQ and pain disability index, PDI),

walking performance (6 min walking test, 6MWT),

depression (Beck Depression Inventory scores, BDI), and

QOL (Short Form 36, SF-36) of all participants were

evaluated. The trunk muscle strength was measured with a

handheld dynamometer. All of the groups showed statisti-

cally significant improvements in pain, disability, muscle

strength, endurance, 6MWT, mobility, QOL, and depres-

sion. The intergroup comparison showed significant dif-

ferences in VAS pain, 6MWT, and EMS, among three

groups. These differences were statistically significant in

groups 2 and 3 compared with the group 1. The intergroup

comparison showed significant difference in pain, physical

function, and energy subgroups of SF-36. The differences

were statistically in group 3 compared with group 1 and 2.

We observed that US and PP treatments were effective in

the treatment of patients with CLBP but PP was not found

to be superior over ultrasound therapy.

Keywords Chronic low back pain � Phonophoresis �Ultrasound � Trunk muscle strength � Pain � Disability �Endurance � Quality of life � Depression

Introduction

Chronic low back pain (CLBP) is a severe health problem,

especially in industrial areas due to its high prevalence and

frequent association with disability [1]. Low back pain

affects 50–80 % of adults at some time during their lives,

and it appears to be an important medical condition with its

consequences. The CLBP gives rise to physical and psy-

chological problems, disability, and deterioration in the

quality of life (QOL) [2].

Chronic low back pain has been found to be associated

with certain postural, muscular, and mobility characteris-

tics. Numerous etiologic factors have been linked with the

condition: Increased lumbar lordosis, decreased abdominal

muscle strength, imbalance between flexor and extensor

trunk muscle strength, reduced spinal mobility. Trunk

muscle strength has been extensively studied in relation to

CLBP. Most of the researchers have found trunk muscle

strength to be an important factor in CLBP [3].

There are various approaches involved in the treatment

of the CLBP. Exercise and stretching have been established

as wellness-focused coping strategies in the management

of CLBP. Along with supervised exercise, they have

D. Durmus (&) � G. Alayli � A. Bilgici � O. Kuru

Department of Physical Medicine and Rehabilitation,

Medical Faculty, Ondokuz Mayis University,

Samsun, Turkey

e-mail: [email protected]

A. S. Goktepe � M. A. Taskaynatan

Gulhane Military Medical Academy,

Department of Physical Medicine and Rehabilitation,

Rehabilitation Hospital, Bilkent, Ankara, Turkey

123

Rheumatol Int

DOI 10.1007/s00296-012-2634-7

Page 2: Is phonophoresis effective in the treatment of chronic low back pain? A single-blind randomized controlled trial

emerged as key clinical recommendations in these cases

[4]. It is recently claimed that exercise therapy is effective

in alleviating the pain and disability as well as increasing

spinal mobility, endurance, proprioception, and strength

[5, 6].

Phonophoresis (PP) uses high-frequency sound waves

(i.e., ultrasound) to deliver therapeutic medications, usually

topical analgesics or steroids, through the skin to deeper

tissues. PP and US therapy is a noninvasive, painless

method that has less side effects and well tolerated, and has

been used in musculoskeletal disorders [7, 8].

The PP therapy has been predominantly used as a pain

reduction modality in the musculoskeletal disorders.

Despite extensive clinical trials of PP, questions remain

regarding treatment effectiveness [7, 9–11]. Additionally,

no study was found in the literature about its effectiveness

in the CLBP treatment.

The objective of this study is to determine and compare

the effects of PP and US therapy on pain, disability, trunk

muscle strength, walking performance, spinal mobility,

QOL, and depression in the patients with CLBP.

Materials and methods

The present study was conducted at the Department of

Physical Medicine and Rehabilitation of Medical Faculty

of ‘‘Ondokuz Mayis University.’’ A total of 64 female

patients who had been experiencing low back pain for at

least 3 months were enrolled in the study. Sixty patients

completed the study (two patients in the US group and two

patients in the control group did not come to the assessment

after 6 weeks).

A demographic data including age, body mass index

(BMI) (kg/m2), educational level, and duration of symp-

toms (years) were recorded. The subjects were housewives,

employee, or they were retired (they had been living a

sedentary life and had no regular or irregular sports habits).

A complete examination was performed by the same

physician.

Study design

This study was a prospective, single-blind randomized

controlled trial. Before treatment, the patients were

informed about the purpose of the study and gave their

consent. The study protocol was approved by the local

ethics committee.

Exclusion criteria were the following: (1) Patients with

acute radicular signs or symptoms, (2) those who had

radiographic evidence of inflammatory disease affecting

the spine, tumor, spondylolysis, spondylolisthesis, or

sacroiliitis, (3) serious medical conditions for which

exercise would be contraindicated, (4) neuromuscular or

dermatologic disease that involves the lomber and

abdominal area, (5) had exercise program that may cause

increase in muscle strength within the previous 6 months

(6) implanted cardiac pacemaker or defibrillator, (7) con-

tracture, (8) previous trauma, (9) the history of the spinal

surgery, (10) the pregnancy, (11) the presence of severe

structural deformity.

Randomization

The patients were randomized into three groups. Ran-

domization was allocated by numbered envelopes method.

The patients were blinded to the treatments. The same

physician who was blind to patients’ clinical data applied

the therapy. Group 1 (n = 20) was accepted as the control

group and was given only exercises. Group 2 (n = 20)

received US treatment and exercises. Group 3 (n = 20)

received PP with capsaicin and exercises. All patients came

to the out-patient department for PP, US, and exercise

treatments. For PP, 10-min duration PP therapy was

applied. For US group, 10-min duration US therapy was

given. For three groups, 60-min duration exercise therapy

was applied. All of the programs were performed 3 days a

week, for duration of 6 weeks. Patients were evaluated

before and at sixth week of the therapy.

The use of NSAID, other analgesic drugs, and anti-

depressant drugs was not permitted during the study period;

any pretreatment with these drugs had to be discontinued

7 days before the start of study. The use of other medica-

tion for comorbid diseases was permitted during study

period. No adverse events had occurred during or after the

PP and US treatments periods.

Phonophoresis therapy

Ultrasound device (Enraf–Nonius Sonopuls 434) was used.

Initially, Gluco Gel containing capsaicin (10 % capsicum

oleoresin in 0.22 % solution) was applied circularly with a

thickness of 2–3 mm. Then, ultrasound with a 5-cm-

diameter applicator was applied over the paravertebral low

back region with 1 MHz frequency and 1.5 Wt/cm2 power.

The treatment duration was 10 min [7].

Ultrasound therapy

The patients also received continuous US using Enraf–

Nonius Sonopuls 434 that operated at 1 MHz frequency

and 1.5 W/cm2 intensity and a transducer head with an area

of 5 cm, an ERA of 4 cm, and a BNR of 1:5. Slow circular

movements were applied by the transducer head over the

paravertebral low back region. The treatment duration was

10 min [7].

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Exercise therapy

Exercises were taught by a physiatrist. The subjects in both

groups were treated with a group-exercise program com-

posed of 60 min back and abdominal exercises with a

warm-up and cool-down period of 10 min stretching

exercises 3 days a week under the supervision of the same

physiatrist. Both groups were given an exercise program,

which consisted of 4 exercises: (1) Motion, flexibility, and

back strengthening exercises of the cervical, thoracic, and

lumbar spine; stretching of the erector spine muscle,

hamstring muscles, pelvic muscles, and abdominal mus-

cles: (1) Pelvic tilt, (2) knee to chest, (3) lower abdominal

exercises, (4) cat and camel, (5) back extension exercises.

(2) Special exercises to correct mobility of the spine and

hip joints, activate the stabilizing muscles of the spine, and

increase flexibility of the lower limb muscles. (3) Func-

tional exercises to improve postural control, dynamic body

balance, and coordination. (4) Progressive relaxation

exercises to normalize muscle tension.

Clinical assessments

The patients were compared before and after the treatment,

in accordance with pain, disability, walking performance,

abdominal and extensor endurance, isometric trunk flexor

muscle strength and extensor muscle strength (EMS), QOL,

and depression. Pain, walking performance, abdominal and

extensor endurance, isometric trunk flexor, and EMS were

measured before treatment and sixth week of the therapy.

Pain and disability

The global pain of the patients was assessed by visual

analog scale (VAS) pain score (0–100 mm, with higher

scores indicating more pain). The Oswestry Disability

Questionnaire (ODQ) and pain disability index (PDI) were

used to assess pain and disability in the study group. ODQ

has 10 subgroups and these are evaluated with 0–5 scores.

Subgroups are pain severity, self-care, walking, sitting,

standing, sexual function, traveling, and social life. The

maximum score in ODQ is 50, which means 100 % dis-

ability [12, 13]. Pain disability index has eight subgroups.

These are social activities, leisure activities, self-care, job,

sexual function, daily life activities. Higher score of the

PDI reflects greater disability [13].

Spinal mobility

The spinal mobility was assessed by lumbar Schober test,

and finger tip to floor distance [14].

Walking performance

The 6-min walk distance (6MWD) test was used as a test of

objective assessment of functional performance and

endurance. Subjects were given the same standard verbal

instructions before each test and instructed to walk their

maximum distance in a 6-min period. The total distance

covered in meters during the 6 min of walking was used as

the score for each session.

Muscle strength

Trunk flexor muscle strength (FMS) and EMS were mea-

sured with a hand-held dynamometer (Baseline Push–Pull

Dynamometer, Digital (LCD) hydraulic New York, USA)

by the same tester. FMS was measured with the subject in

supine, arms resting at side, head mid-line. The end piece

of the dynamometer was applied on the sternum at the

center of the chest. Subject was asked to take 1 or 2 s to

come to maximum effort and then, tester pushed down

body as forcefully as possible. EMS was measured with the

subject in prone, arms resting at side, head mid-line. The

end piece of the dynamometer was applied at the inferior

angle of the scapulae at the center of the back between the

shoulder blades. Subject was asked to take 1 or 2 s to come

to maximum effort and then, tester pushed down body as

forcefully as possible. The maximum force realized during

a 3- to 5-s effort was recorded in kilogram. The test was

performed three times with a 30-s interval and the average

was recorded. Muscle strength was measured before

treatment and third- and sixth week of the therapy.

Endurance

The subject is placed prone with the legs extended while

holding the sternum of the floor. A small pillow is placed

under the lower abdomen to decrease the lumbar lordosis.

The subject is asked to maintain maximal flexion of the

cervical spine, pelvic stability being maintained through

gluteal muscle contraction. Subject is asked to maintain

this position as long as possible, to a maximum of 300 s.

Endurance time (in s) is recorded by an examiner (extensor

endurance test) [15].

The flexor endurance test required subjects to sit on the

test bench and place the upper body against a support with

an angle of 60� from the test bed. Both the knees and hips

were flexed to 90�. The arms were folded across the chest

with the hands placed on the opposite shoulder and toes

were placed under toe straps. Subjects were instructed to

lift their upper body away from the support and keep it

parallel with the support (as instructed by the examiner).

Subjects were instructed to maintain the body position as

long as possible. The test ended when the upper body fell

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below the 60� angles and came in contact with the back

support. Endurance time (in s) is recorded by an examiner

[16].

Quality of life

Quality of life was assessed with Short Form 36 (SF-36).

The SF-36 is a widely applied generic instrument for

measuring health status and consists of eight dimensions:

Physical functioning, social functioning, physical role,

emotional role, mental health, vitality, bodily pain, and

general health perceptions. Scores range from 0 (worst) to

100 (best) with higher scores indicating better health status

[17].

Depression

Depression was assessed with Beck Depression Inventory

(BDI). BDI is a 21-item test presented in multiple-choice

format, which purports to measure presence and degree of

depression. Responses are made on a four-point, minimally

anchored scale, ranging from 0 to 3, with 3 representing the

most severe symptoms [18].

Statistical analysis

Statistical analyses were performed with SPSS 16.0 for

windows. Descriptive data were presented as

mean ± standard deviation (SD) or minimum–maximum

(median) when needed according to the normal distribution

of the parameters. The Shapiro–Wilk test was used to

analyze normal distribution assumption of the quantitative

outcomes. Baseline, and after treatment, clinical charac-

teristics between groups were compared using the non-

parametric Kruskal–Wallis or one-way ANOVA tests.

Wilcoxon’s signed rank test or paired t test was used to

determine within-group change, used when needed

according to the normal distribution of the parameters. The

sociodemographical characteristics of the groups were

evaluated by Chi-square test. p values less than 0.05 were

considered statistically significant.

Results

Demographic properties of the patients are shown in

Table 1. There was no statistically significant difference

for age, gender, BMI, duration of symptoms, job, and

education between groups (p [ 0.05).

There was also no significant difference between the

groups in terms of pain, disability, walking performance,

trunk muscle strength, endurance, mobility, QOL, and

depression scores before treatment (p [ 0.05).

All of the groups showed statistically significant

improvements in pain, disability, muscle strength, endur-

ance, walking performance, mobility, subscores of SF-36,

and depression when compared with their initial status

(Tables 2, 4). The intergroup comparison showed signifi-

cant difference in VAS pain, walking performance, and

EMS, between three groups. This difference was statisti-

cally significant in the groups 2 and 3 compared with the

group 1. There was also no significant difference between

the groups 2 and 3 (Table 3).

The intergroup comparison showed significant differ-

ence in pain, physical function, and energy subgroups of

SF-36 between three groups. This difference was statisti-

cally significant in the group 3 compared with the group 1

and group 2. There was also no significant difference

between the groups 1 and 2 (Table 5).

Discussion

The aim of the treatment in the CLBP is to decrease pain,

to increase mobility, to prevent disability, and to improve

QOL and physical functions. To attain these aims, various

treatment programs are suggested. Medical treatment,

physical therapy, superficial, deep heat applications, elec-

trotherapy, massage, and traction, and exercises are the

therapies often administered. The physical therapy

modalities are usually used in combinations together with

the exercises. The effects of the physical therapy modali-

ties on the CLBP have been shown in uncontrolled studies.

There are few randomized controlled studies investigating

the effect of these modalities and there is no consensus on

which treatment methods are more effective [7, 19–21].

This study was planned as a randomized single-blind

controlled study in which efficacy of PP with capsaicin gel,

US and exercise methods on pain, disability, trunk muscle

strength, walking performance, spinal mobility, QOL, and

depression was investigated in the patients with CLBP. The

results of this study showed greater improvements in pain,

EMS, and walking performance in the PP group and US

group than the control group. However, there was no dif-

ference in terms of efficacy between the PP and US

treatment.

While using US, the gate control mechanism could be

mentioned again due to excitation of A-b mechanorecep-

tors. In this condition, messages produced from mechano-

receptors enter the spinal cord and quick pain impulses at

the spinal cord become inhibited and pain would be

blocked [22]. Therapeutic US is proposed to deliver energy

to deep tissue sites through ultrasonic waves, to produce

increases in tissue temperature or nonthermal physiologic

changes. Ultrasonic energy causes soft tissue molecules to

vibrate from exposure to the acoustic wave. This increased

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molecular motion generates frictional heat, thus increasing

tissue temperature. Referred to as ultrasound’s ‘‘thermal

effects,’’ this heating is proposed to increase collagen

extensibility, increase nerve conduction velocity, alter local

vascular perfusion, increase enzymatic activity, alter con-

tractile activity of skeletal muscle, and increase nociceptive

threshold [23].

PP is the penetration of the topical medicines transder-

mal to the subcutaneous tissues via US. The mechanism of

PP is increasing the cell permeability via thermal effects of

the US and inducing transdermal migration by doing local

vasodilatation [7, 24, 25].

At Philadelphia panel, it was reported that there is no

scientific evidence which shows the clinical efficacy of US

Table 1 Demographic

properties of the patients

p \ 0.05 Significant

Group 1 (n = 20)

mean ± SD

Group 2 (n = 20)

mean ± SD

Group 3 (n = 20)

mean ± SD

p

Age (year) 53.25 ± 7.45 48.70 ± 8.88 54.65 ± 8.79 0.131

BMI (kg/m2) 27.85 ± 2.43 29.05 ± 3.94 28.05 ± 3.89 0.802

Duration of symptoms (year) 7.80 ± 4.17 11.30 ± 8.11 11.40 ± 8.80 0.438

Job n (%)

Housewife 4 (20.0) 11 (55.0) 9 (45.0) 0.165

Retired 12 (60.0) 5 (25.0) 7 (35.0)

Employee 4 (20.0) 4 (20.0) 4 (20.0)

Education n (%)

Primary education 8 (40.0) 9 (45.0) 10 (50.0) 0.600

Secondary education 4 (20.0) 4 (20.0) 3 (15.0)

College 8 (40.0) 7 (35.0) 7 (35.0)

Smoking status n (%)

Yes 10 (50.0) 8 (40.0) 7 (35.0) 0.680

No 10 (50.0) 12 (60.0) 13 (65.0)

Table 2 Baseline and the final results of clinical parameters of the patients

Group 1 Group 2 Group 3

BT

mean ± SD

AT

mean ± SD

p BT

mean ± SD

AT

mean ± SD

p BT

mean ± SD

AT

mean ± SD

p

Lomber

shober

(cm)

14.17 ± 1.09 14.55 ± 1.05 0.001 14.27 ± 0.86 14.60 ± 0.92 0.007 13.87 ± 1.07 14.35 ± 0.94 0.003

Finger tip

to floor

distance

(cm)

2.60 ± 5.73 1.65 ± 3.51 0.042 3.05 ± 5.50 2.10 ± 5.33 0.007 3.25 ± 7.48 0.70 ± 1.49 0.012

PDI 17.35 ± 1.24 6.70 ± 4.55 0.001 14.70 ± 1.10 6.60 ± 4.47 0.001 16.25 ± 7.61 4.90 ± 4.06 0.001

ODQ (%) 13.75 ± 6.71 5.55 ± 3.76 0.001 12.75 ± 4.56 4.95 ± 3.31 0.001 16.55 ± 3.99 3.65 ± 2.30 0.001

6MWT 484.40 ± 70.79 576.35 ± 50.08 0.001 487.30 ± 74.15 619.40 ± 66.84 0.001 495.65 ± 80.60 639.10 ± 73.85 0.001

VAS pain

(cm)

6.10 ± 1.99 3.05 ± 1.50 0.001 5.55 ± 1.27 1.35 ± 1.30 0.001 6.80 ± 1.82 1.25 ± 1.20 0.001

FMS (kg) 17.15 ± 2.36 23.20 ± 1.67 0.001 17.70 ± 2.88 23.85 ± 1.13 0.001 18.40 ± 2.34 23.86 ± 1.72 0.001

EMS (kg) 19.85 ± 2.03 27.55 ± 2.87 0.001 20.80 ± 2.89 30.85 ± 2.66 0.001 21.70 ± 3.06 31.00 ± 3.00 0.001

AET (sn) 43.95 ± 2.78 89.25 ± 4.91 0.001 53.00 ± 3.89 93.25 ± 4.48 0.001 38.55 ± 2.07 91.15 ± 4.57 0.001

EET (sn) 49.50 ± 4.04 126.65 ± 5.66 0.001 54.90 ± 5.04 164.00 ± 7.33 0.001 41.40 ± 2.50 130.81 ± 5.85 0.001

ODQ the Oswestry Disability Questionnaire, PDI pain disability index, BT before treatment, AT after treatment, 6MWT 6-min walking test, VASpain visual analog scale, FMS flexor muscle strength, EMS extensor muscle strength, AET flexor endurance test, EET extensor endurance test,

Mean ± SD mean ± standard deviation

p \ 0.05 Significant

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on chronic back pain [26, 27]. Similarly, Ebadi et al. [23]

reported that clinical efficacy of US is not a scientific

evidence. Controversially, in ‘‘Quebec Task Force’’ (QTF),

the application of US therapy with hot treatment was

reported as a good choice at the treatment of muscle spasm

and reducing symptomatic pain [28]. Grubisic et al. [29]

investigated the efficacy of US therapy on 31 patients with

chronic back pain. They found more reduced pain intensity

at US group than placebo group. Similar to these studies,

we showed more reduced pain intensity in US group than

exercise group. At the same time, we found that US may

increase muscle performance by heating the deep tissues

and can help the increase in the extensor muscle force and

QOL.

There are limited randomized controlled studies

regarding the efficacy of US and PP on musculoskeletal

system in the literature. Also, to the best of our knowledge,

there is no study comparing the effectiveness of these

Table 3 Comparison of the final results of clinical parameters of the patients

Group 1

TS

mean ± SD

Group 2

TS

mean ± SD

Group 3

TS

mean ± SD

p

Lomber shober (cm) 14.55 ± 1.05 14.60 ± 0.92 14.35 ± 0.94 0.513

Finger tip to floor distance (cm) 1.65 ± 3.51 2.10 ± 5.33 0.70 ± 1.49 0.666

PDI 6.70 ± 4.55 6.60 ± 4.47 4.90 ± 4.06 0.273

ODQ (%) 5.55 ± 3.76 4.95 ± 3.31 3.65 ± 2.30 0.291

6MWTa, b 576.35 ± 50.08 619.40 ± 66.84 639.10 ± 73.85 0.024

VAS pain (cm)a, b 3.05 ± 1.50 1.35 ± 1.30 1.25 ± 1.20 0.001

FMS (kg) 23.20 ± 1.67 23.85 ± 1.13 23.86 ± 1.72 0.437

EMS (kg)a, b 27.55 ± 2.87 30.85 ± 2.66 31.00 ± 3.00 0.001

AET (sn) 89.25 ± 4.91 93.25 ± 4.48 91.15 ± 4.57 0.827

EET (sn) 126.65 ± 5.66 164.00 ± 7.33 130.81 ± 5.85 0.132

ODQ the Oswestry Disability Questionnaire, PDI pain disability index, M. Lomber Shober modified lomber shober, AT after treatment, 6MWT6-min walking test, VAS pain visual analog scale, FMS flexor muscle strength, EMS extensor muscle strength, AET Flexor endurance test, EETextensor endurance test, Med (min–max) median (minimum–maximum), Mean ± SD mean ± standard deviation

p \ 0.05 Significant

a Significant difference between group 1 and 2

b Significant difference between group 1 and 3

Table 4 Baseline and the final results of quality of life, depression of the patients

Group 1 Group 2 Group 3

BT

mean ± SD

AT

mean ± SD

p BT

mean ± SD

AT

mean ± SD

p BT

mean ± SD

AT

mean ± SD

p

Depression 8.80 ± 7.54 4.65 ± 4.28 0.001 6.50 ± 3.28 3.90 ± 2.86 0.001 6.25 ± 2.80 3.00 ± 2.91 0.001

SF-36

Physical

function

73.25 ± 12.6 89.75 ± 11.1 0.001 70.00 ± 13.3 87.00 ± 11.4 0.001 76.75 ± 11.1 96.00 ± 38.3 0.001

Mental health 56.60 ± 10.1 74.10 ± 10.1 0.001 58.40 ± 10.8 73.40 ± 12.2 0.001 64.05 ± 14.2 80.40 ± 12.5 0.001

Pain 65.50 ± 17.69 77.45 ± 12.48 0.001 58.65 ± 16.23 77.20 ± 11.44 0.001 62.10 ± 20.86 86.55 ± 7.89 0.001

General health 50.25 ± 14.46 66.75 ± 14.26 0.001 51.75 ± 15.24 61.00 ± 16.59 0.001 55.00 ± 12.97 71.75 ± 19.07 0.001

Social function 58.85 ± 14.39 86.10 ± 13.09 0.001 54.45 ± 13.57 84.35 ± 12.01 0.001 52.25 ± 19.17 89.15 ± 8.77 0.001

Physical role

limitation

60.65 ± 31.2 90.75 ± 15.2 0.001 56.25 ± 33.3 96.75 ± 8.1 0.001 57.50 ± 34.5 94.50 ± 9.01 0.001

Emotional role

limitation

62.55 ± 26.9 89.05 ± 18.5 0.001 61.30 ± 29.2 96.05 ± 9.91 0.001 54.65 ± 31.1 91.75 ± 11.7 0.001

Energy 53.50 ± 12.7 72.50 ± 10.4 0.001 55.75 ± 14.0 69.00 ± 15.09 0.001 59.25 ± 10.9 82.65 ± 15.72 0.001

BT before treatment, AT after treatment, SF-36 short form 36, Mean ± SD mean ± standard deviation

p \ 0.05 Significant

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methods in CLBP. Kozanoglu et al. [30] compared the

effectiveness of 5 % ibuprofen PP and US treatment in the

patients with knee OA. While the authors determined sig-

nificant improvements in pain severity, walking perfor-

mance in both groups, they reported that PP was not

superior over ultrasound therapy. In a recent study, Ay

et al. [7] investigated the effects of diclofenac PP in active

myofascial pain syndrome. Their results showed significant

improvements in all parameters, but no significant differ-

ences between diclofenac PP and US. In another study

performed in the patients with tendinit, epicondilit, and

tenosynovitis, using 0.05 % fluocinonide, PP was found

having no additive effect [31]. Different topical drugs such

as local anesthetics, anti-inflammatory drugs (steroidal and

nonsteroidal medications) are used in PP. We used a top-

ical gel containing capsaicin. Capsaicin binds to nocicep-

tors in the skin, causing an initial excitation of the neurones

and a period of enhanced sensitivity. This is usually per-

ceived as itching, pricking, or burning, with cutaneous

vasodilation, and is thought to be due to selective stimu-

lation of afferent C fibers and release of substance P. In the

present study, we found that both US and capsaicin PP

were effective for treatment of CLBP. Since there was no

significant difference between the treatment groups

regarding the clinical findings, the improvements in PP

group may be attributed to the effects of US [32].

In a randomized double-blind study including 20 patients

with temporomandibular joint pain, the efficiency of PP

using 1 % indometacin was compared with placebo and

significant decrease in pain was observed [33]. Javad Sar-

rafzadeh et al. [22] showed that both US and PP with

hydrocortisone were effective for treatment of myofascial

pain syndrome.

A recent systematic review [34] of exercise therapy for

LBP concluded that exercise therapy overall was not

effective for patients with acute LBP but may be helpful for

those with CLBP. Systematic reviews have repeatedly

determined that, on average, exercise for CLBP seems to

be effective in decreasing pain and improving function [35,

36]. Although a recent Cochrane review found that exercise

is an effective treatment for LBP, no specific exercise

programs showed a clear advantage for that application

[37]. Today, the significance of core strengthening has

been increasingly recognized in various areas involved in

the management of LBP [4, 38, 39].

Our study also has some limitations. One of them is the

relatively small number of patients in each group. Future

studies should include larger populations. Investigating the

short-term effects of treatment methods is also one of the

limitations of the present study.

We determined that US and PP were effective in

patients with CLBP. However, we did not determine any

difference in terms of efficacy between the US and PP

treatment except some parameters of SF-36. A combination

of US or PP with exercises can be used to obtain optimal

clinical results. PP and US may, therefore, become a

valuable treatment modality for patients with CLBP before

the exercise and conditioning programs. In conclusion, we

can say that a combination of PP or US therapy with

exercises provides comfortable life functions by improving

pain, muscle strength, and QOL.

Acknowledgments The authors thank Tulin Durmus for the assis-

tance for the editing of the manuscript.

Conflict of interest None.

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