Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000978369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/03/2026
Date registered
Help: Date registered
10/08/2026
Date last updated
Help: Date last updated
10/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of different doses of shockwave therapy on pain and function in adults with chronic non-specific low back pain.
Scientific title
The effectiveness of different dose responses of shockwave therapy on pain, mobility, disability, and quality of life in adults with chronic non-specific low back pain
Additional trial identifiers [1] 316702 0
NONE
Universal Trial Number (UTN)
U1111-1336-7412
Trial acronym
DRESS-LBP Trial
Related trial records

Health condition
Health condition(s) studied:
Chronic Non-Specific Low Back Pain 340952 0
Condition category
Condition code
Musculoskeletal 337105 337105 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Dose–Response Extracorporeal Shockwave Therapy (ESWT) Program for Chronic Non-Specific Low Back Pain

This study is a four-arm, assessor-blinded randomized controlled trial comparing three frequency parameters of radial Extracorporeal Shockwave Therapy (rESWT) with conventional physiotherapy in adults with Chronic Non-Specific Low Back Pain (CNSLBP).

Arm 1: Low-Frequency ESWT (5 Hz)

Materials and Procedure:

Shockwave therapy will be administered using a Radial Extracorporeal Shockwave Therapy (rESWT) device. Prior to treatment, standard ultrasound transmission gel will be applied to the lumbar paraspinal region (L3–S1) to ensure effective transmission of shockwaves. The therapy will target painful and tender areas identified during assessment by using slow circular and longitudinal application over affected tissues. A standardized treatment protocol checklist will be followed during each session to maintain consistency, and all treatment details will be documented using session recording log sheets. The intervention will be delivered face-to-face in individual sessions by a licensed physiotherapist with a minimum of five years of musculoskeletal clinical experience and certified training in Extracorporeal Shockwave Therapy (ESWT).

Frequency: 5 Hz

Impulses: 2000 shocks per session

Energy intensity will be titrated to participant tolerance within predefined therapeutic limits.

Dose & Schedule:
2 sessions per week
4 weeks duration
Total 8 sessions
Each session: 15–20 minutes

Location
Physiotherapy Department, Pakistan Air Force (PAF) Hospital (outpatient setting)



Arm 2: Medium-Frequency ESWT (10 Hz)

All procedures identical to Arm 1 except:

Frequency: 10 Hz

Impulses: 2000 shocks per session

Energy intensity will be titrated to participant tolerance within predefined therapeutic limits.

Dose & Schedule:
2 sessions per week
4 weeks duration
Total 8 sessions
Each session: 15–20 minutes

Location
Physiotherapy Department, Pakistan Air Force (PAF) Hospital (outpatient setting)




Arm 3: High-Frequency ESWT (15 Hz)

All procedures identical to Arm 1 except:

Frequency: 15 Hz

Impulses: 2000 shocks per session

Energy intensity will be titrated to participant tolerance within predefined therapeutic limits.

Dose & Schedule:
2 sessions per week
4 weeks duration
Total 8 sessions
Each session: 15–20 minutes

Location
Physiotherapy Department, Pakistan Air Force (PAF) Hospital (outpatient setting)



2: Strategies used to assess and monitor adherence and fidelity to the intervention will include:

Use of a standardized treatment protocol checklist to ensure all treatment procedures are delivered consistently across participants and sessions.
Maintenance of session recording log sheets documenting treatment parameters, session duration, attendance, and any deviations from the protocol.
Direct observation or periodic supervision of treatment sessions by a senior physiotherapist or research supervisor to confirm protocol compliance.
Monitoring participant attendance and completion of all scheduled sessions to assess adherence to the intervention schedule.
Training and certification of the treating physiotherapist to maintain standardized intervention delivery.
Intervention code [1] 333380 0
Treatment: Devices
Intervention code [2] 333381 0
Rehabilitation
Intervention code [3] 333382 0
Lifestyle
Description of the comparator or control
Arm 4: Control Group – Conventional Physiotherapy

Materials and Procedure

Participants in the control group will receive standardized conservative physiotherapy. Superficial heat therapy will be applied using a standard hydrocollator moist heat pack wrapped in towels and placed over the lumbar region for 15–20 minutes at a therapeutic temperature of approximately 40–45°C.

Transcutaneous Electrical Nerve Stimulation (TENS) will be administered using a conventional TENS unit with surface electrodes placed over the painful lumbar region. Conventional high-frequency stimulation 100 Hz with a pulse duration of 100 µs will be applied for approximately 20 minutes according to patient tolerance.

Participants will also perform supervised exercise therapy including lumbar mobility exercises such as pelvic tilts, knee-to-chest stretches, lumbar rotation stretches, and cat-camel exercises. Core stabilization exercises will include bridging, bird-dog exercises, and modified planks. Stretching exercises targeting the hamstrings and lumbar musculature will be included, along with functional retraining exercises such as sit-to-stand practice, bending and lifting training, walking drills, and posture correction activities.

Provider

The intervention will be delivered by a licensed physiotherapist with a minimum of three years of musculoskeletal clinical experience.

Mode of Delivery
Face-to-face
Individual sessions

Dose & Schedule
2 sessions per week
4-week duration
Total of 8 sessions
Each session approximately 30–40 minutes

Location
Physiotherapy Department, Pakistan Air Force (PAF) Hospital (outpatient setting)
Control group
Active

Outcomes
Primary outcome [1] 344620 0
Pain Intensity
Timepoint [1] 344620 0
Baseline: Day 1 and Post Intervention: Week 4
Primary outcome [2] 344621 0
Functional Disability
Timepoint [2] 344621 0
Baseline: Day 1 and Post Intervention: Week 4
Secondary outcome [1] 458665 0
Lumbar range of motion
Timepoint [1] 458665 0
Baseline: Day 1 and Post Intervention: Week 4
Secondary outcome [2] 458666 0
Fear of movement
Timepoint [2] 458666 0
Baseline: Day 1 and Post Intervention: Week 4
Secondary outcome [3] 458667 0
Psychosocial risk
Timepoint [3] 458667 0
Baseline: Day 1 and Post Intervention: Week 4
Secondary outcome [4] 458668 0
Quality of Life
Timepoint [4] 458668 0
Baseline: Day 1 and Post Intervention: Week 4
Secondary outcome [5] 458669 0
Inflammatory biomarkers
Timepoint [5] 458669 0
Baseline: Day 1 and Post Intervention: Week 4

Eligibility
Key inclusion criteria
a) Adults aged 18–60 years
b) Physician Diagnosis of CNSLBP (More than 3 months)
c) The pain is typically located in the area between the costal margins (ribs) and
the gluteal folds.
a. Symptoms and Signs: The primary symptom is low back pain (LBP). This may
be included with or without referred leg pain (e.g., pain above the knee), as long
as it does not meet the criteria for a specific pathology like radiculopathy.
d) Visual Analogue Scale (VAS) pain score equal or more than 3/10
e) Oswestry Disability Index (ODI) equal or more than 30 %
f) Able to follow instructions and complete questionnaires
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
a) Specific LBP causes: disc herniation, spinal stenosis, spondylolisthesis,
ankylosing spondylitis, tumors, fractures, infections
b) Neurological deficits
c) Pregnancy
d) Contraindications to shockwave therapy (anticoagulant therapy, metal implants
in region, coagulation disorders, severe osteoporosis)
e) Severe psychological conditions that might confound the pain or treatment
response MINI Cog (e.g., severe depression, active substance abuse).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants meeting the eligibility criteria for CNSLBP will be chosen from the
Physiotherapy Department of PAF Hospital Group. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes (SNOSE). Each envelope will be opened only after the participant has been deemed eligible and has provided informed consent, ensuring that the recruiter remains unaware of the upcoming group assignment at the time of enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed using a computer
generated sequence to minimize allocation bias.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is a four-arm randomized controlled trial comparing three frequencies of extracorporeal shockwave therapy (5 Hz, 10 Hz, 15 Hz) with conventional physiotherapy in adults with chronic non-specific low back pain. Participants will be randomly allocated using a computer-generated sequence. Outcomes will be assessed at baseline, post-intervention (4 weeks) follow-up by an assessor.

Data will be analyzed using SPSS (version 25 or higher). Descriptive statistics (mean, standard deviation, frequencies) will summarize baseline characteristics and outcome measures. Normality will be assessed using the Shapiro–Wilk test, and assumptions of homogeneity and sphericity will be tested before inferential analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2026
Date of last participant enrolment
Anticipated
30/08/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
120
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 27879 0
Pakistan
State/province [1] 27879 0
Islamabad

Funding & Sponsors
Funding source category [1] 321307 0
Self funded/Unfunded
Name [1] 321307 0
Country [1] 321307 0
Primary sponsor type
University
Name
LINCOLN UNIVERSITY COLLEGE, MALAYSIA
Address
Country
Malaysia
Secondary sponsor category [1] 324036 0
Hospital
Name [1] 324036 0
PAKISTAN AIR FORCE HOSPITAL, ISLAMABAD
Address [1] 324036 0
Country [1] 324036 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319839 0
PAF HOSPITAL ETHICAL RESEARCH COMMITTEE ISLAMABAD
Ethics committee address [1] 319839 0
Ethics committee country [1] 319839 0
Pakistan
Date submitted for ethics approval [1] 319839 0
20/02/2026
Approval date [1] 319839 0
12/03/2026
Ethics approval number [1] 319839 0
260312

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148574 0
Dr Umair ur Rehman
Address 148574 0
PAKISTAN AIR FORCE HOSPITAL (PAF) E-9 MAIN MARGALLA ROAD, ISLAMABAD, 44000
Country 148574 0
Pakistan
Phone 148574 0
+923455881060
Fax 148574 0
Email 148574 0
[email protected]
Contact person for public queries
Name 148575 0
PHYSIOTHERAPY AND REHABILITATION DEPARTMENT PAF HOSPITAL ISLAMABAD
Address 148575 0
PAKISTAN AIR FORCE HOSPITAL (PAF) E-9 MAIN MARGALLA ROAD, ISLAMABAD, 44000
Country 148575 0
Pakistan
Phone 148575 0
+92519564330
Fax 148575 0
Email 148575 0
[email protected]
Contact person for scientific queries
Name 148576 0
PHYSIOTHERAPY AND REHABILITATION DEPARTMENT PAF HOSPITAL ISLAMABAD
Address 148576 0
PAKISTAN AIR FORCE HOSPITAL (PAF) E-9 MAIN MARGALLA ROAD, ISLAMABAD, 44000
Country 148576 0
Pakistan
Phone 148576 0
+92519564330
Fax 148576 0
Email 148576 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    PAF ETHICAL RESEARCH FORM.pdf
Informed consent form    PATIENT CONSENT AND QUESSIONAIRES.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.