| CTRI Number |
CTRI/2025/11/097194 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Exploring the Effectiveness of Shortwave Diathermy in Patients with Chronic Low Back Pain |
|
Scientific Title of Study
|
Effectiveness of Shortwave Diathermy in Patients with Chronic Low Back Pain: A Randomized Single-Blinded Multicenter Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Ali |
| Designation |
Consultant |
| Affiliation |
Uttara Adhunik Medical College and Hospital |
| Address |
Department of Physiotherapy and Rehab, Room no-01
1230
Other |
| Phone |
01715043533 |
| Fax |
|
| Email |
drmali2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammad Ali |
| Designation |
Consultant |
| Affiliation |
Uttara Adhunik Medical College and Hospital |
| Address |
Department of Physiotherapy and Rehab,Room 1
1230
Other |
| Phone |
01715043533 |
| Fax |
|
| Email |
drmali2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Ali |
| Designation |
Consultant |
| Affiliation |
Uttara Adhunik Medical College and Hospital |
| Address |
Department of Physiotherapy and Rehab, Room 1
1230
Other |
| Phone |
01715043533 |
| Fax |
|
| Email |
drmali2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hasna Hena Pain Physiotherapy and Public Health Research Center (HPRC), Uttara, Dhaka-1230, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
Mohammad Ali |
| Address |
Department of Physiotherapy and Rehab, Room no 1, House 34, Road 04, Sector 09, Uttara, Dhaka 1230, Bangladesh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Md Abu Alam |
Ad-Din Medical College Hospital |
Department of Physiotherapy, Room no 100.
|
8801515634808
mdabualamho@gmail.com |
| Saddam Hossain |
Asia Digital Physiotherapy and Orthopedic Rehabilitation Center |
Department of Physiotherapy, Room no 1
|
8801950935236
shossainrasel@gmail.com |
| Abu Bakar Arfan |
Japan Bangladesh College of physiotherapy and Health sciences |
Department of Physiotherapy, Room no 500
|
8801521205620
abubakarafran@gmail.com |
| Mehedi Hasan |
Mayfair Wellness Clinic Ltd. |
Department of Physiotherapy Room no 1
|
8801682348491
mhmehedi20@gmail.com |
| Md Amran Hossain |
Mi care health and research |
Department of physiotherapy, Room 200
|
8801920603090
imranbinnoman@gmail.com |
| Mohammad Ali |
Uttara Adhunik Medical College Hospital |
Department of physiotherapy and rehab, room no 1
|
8801715043533
alibup2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethical Review Committee of Uttara Adhunik Medical College |
Approved |
| Ethical Review Committee of Uttara Adhunik Medical College |
Approved |
| Ethical Review Committee of Uttara Adhunik Medical College |
Approved |
| Ethical Review Committee of Uttara Adhunik Medical College |
Approved |
| Ethical Review Committee of Uttara Adhunik Medical College |
Approved |
| Ethical Review Committee of Uttara Adhunik Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, (2) ICD-10 Condition: M190||Primary osteoarthritis of other joints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Short Wave Diathermy |
- Pulsed SWD (27.12 MHz, 100–150 W, 20 min per session, 3 session per week for 4 weeks) using Webstar-500 SWD machine. - Combined with standard physiotherapy (stretching, core stabilization) as needed for the specific patients. |
| Comparator Agent |
Sham Short Wave Diathermy group |
Identical setup of Short wave diathermy (SWD) group but with no active SWD emission:
- Pulsed SWD (27.12 MHz, 100–150 W, 20 min per session, 3 session per week for 4 weeks) using Webstar-500 SWD machine.
- Combined with standard physiotherapy (stretching, core stabilization) as needed for the specific patients. |
| Comparator Agent |
Short Wave Diathermy |
Short Wave Diathermyh (SWD) Group:
- Pulsed SWD (27.12 MHz, 100–150 W, 20 min per session, 3 session per week for 4 weeks) using Webstar-500 SWD machine.
- Combined with standard physiotherapy (stretching, core stabilization) as needed for the specific patients.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. A primary complaint of either:
a. low back pain, defined as pain between the inferior costal margin and the inferior gluteal fold with or without referral into the leg(s)
or
b. referred leg pain without back pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, presumed to be of lumbar spine origin.
2. Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury)
3. Aged between 18 and 65 (inclusive)
4. Fluency in Bangla or English sufficient to complete questionnaires and to enable understanding of the intervention
5. Agreeing to refrain from other interventions wherever possible for the 10-week treatment period of the trial, aside from consultations with medical practitioners, medication, and
any exercises already being undertaken
|
|
| ExclusionCriteria |
| Details |
1. Active cancer under current treatment, as the treatment of cancer may interfere with their ability to participate in the trial
2. Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging
3. Current pregnancy, or childbirth within the last 6 months, as this could impair the ability to undertake exercises, and could also cause back and leg symptoms that are not related to
the subgroups under investigation
4. Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections
5. Any history of lumbar spine surgery, as there is already considerable research evaluating the efficacy of post-surgical rehabilitation programs
6. A pain intensity score of less than 2/10 on a 0-10 numerical rating scale due to low severity
7. Minimal activity limitation, evidenced by a baseline ability to walk, sit, and stand for one hour or more and no sleep disturbance at night, as we wish to exclude people with low
severity
8. Already received more than 5 sessions of physiotherapy with any of the treating physiotherapists before enrolment, as this could influence treatment expectations in patients
9. Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants
10. Planned absence of more than one week during the treatment period (such as extended holidays) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Back pain intensity (0-10 numerical rating
scale)
2. Leg pain intensity (0-10 numerical rating
scale)
3. Activity limitation: Oswestry Disability
Index V2.1 with sex life question replaced
by a work or housework question |
Baseline, 4 weeks, 12 weeks and 24 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Brief Pain Inventory: pain severity and pain
interference
2. Global rating of change scale (7-point Likert
scale)
3. Satisfaction with treatment (5-point Likert
scale)
4. Interference with work or housework in the
past week (5-point Likert scale), and number
of work hours missed in the last 7 days
5. Orebro ¨
Musculoskeletal Pain Screening
Questionnaire Short Form (¨OMPSQ-SF)
6. Quality of life (EuroQol-5D-5L)
7. Depression Anxiety and Stress Scale (DASS-
21)
8. Pain Self-Efficacy questionnaire (PSEQ)
9. Pain Catastrophizing Scale (PCS)
10. Insomnia Severity Index (ISI)
11. Central Sensitisation Inventory 9 (CSI-9)
12. Clinical inflammation score
13. Treatment Credibility Questionnaire
14. Healthcare utilisation (participant diary
tracking health service utilisation,
imaging, medication) |
Baseline, 4 weeks, 12 weeks and 24 weeks. |
|
|
Target Sample Size
|
Total Sample Size="208"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Effectiveness of Shortwave Diathermy in Patients with Chronic Low Back Pain: A Randomized Single-Blinded Multicenter Clinical Trial Summary: This is a proposed randomized, single-blinded, multicenter clinical trial designed to evaluate the effectiveness of Shortwave Diathermy (SWD) for chronic low back pain (CLBP). The study will enroll 140 adults with CLBP and randomly assign them to one of two groups: one receiving active SWD plus standard physiotherapy and the other receiving sham SWD plus standard physiotherapy. The primary goal is to determine if active SWD is more effective than a sham procedure at reducing pain (measured on a Visual Analog Scale) and improving functional outcomes over a 4-week intervention period with a 3-month follow-up. The study aims to provide high-quality evidence to either support the integration of SWD into CLBP treatment guidelines or to discourage its use if it proves ineffective. |