| CTRI Number |
CTRI/2026/01/101433 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Using Technology-assisted exercise programs and Relaxation therapy to Reduce Pain and Improve Well-Being in Fibromyalgia |
|
Scientific Title of Study
|
VIRTUAL REALITY-ASSISTED EXERCISE PROGRAM IN COMBINATION WITH GUIDED IMAGERY ON PATIENT-REPORTED SYMPTOMS IN FIBROMYALGIA |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kartika Agarwal |
| Designation |
Post graduate student |
| Affiliation |
SGT university |
| Address |
SGT University B Block 4th floor Room no: 418 Department of Physiotherapy
SGT University B Block 4th floor Room no: 418 Department of Physiotherapy
Gurgaon
HARYANA
122505
India |
| Phone |
06377849236 |
| Fax |
|
| Email |
kartikaagarwal083@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Rishi |
| Designation |
Associate Professor |
| Affiliation |
SGT University |
| Address |
SGT University B Block 4th floor Department of Physiotherapy
SGT University B Block 4th floor Department of Physiotherapy
Gurgaon
HARYANA
122505
India |
| Phone |
8588878467 |
| Fax |
|
| Email |
Priyanka.sphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Kartika Agarwal |
| Designation |
Post graduate student |
| Affiliation |
SGT university |
| Address |
SGT University B Block 4th floor Room no: 418 Department of Physiotherapy
SGT University B Block 4th floor Room no: 418 Department of Physiotherapy
Gurgaon
HARYANA
122505
India |
| Phone |
06377849236 |
| Fax |
|
| Email |
kartikaagarwal083@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kartika agarwal |
| Address |
SGT University, Gurugram, Haryana, 122505 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrKartika Agarwal |
SGT Hospital and Research institute |
SGT University B Block 4th floor Room no: 418 Department of Physiotherapy
Gurgaon
HARYANA |
06377849236
kartikaagarwal083@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M797||Fibromyalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guided Imagery |
Guided imagery (GI), a form of mind–body therapy, has been shown to reduce pain intensity, improve mood, and enhance coping strategies in fibromyalgia- 15 min Virtual reality (VR) technology immerses patients in a computer-generated environment that closely resembles the real world, enabling interactive experiences- 20 min Fibromyagia education- 5mins |
| Comparator Agent |
conventional training |
Fibromyalgia Education- 5 mins
MOBILITY EXERCISES
1.Neck gentle ROM( Flexion, extension, lateral flexion, rotation)
2. Shoulder rolls
(Clockwise and anticlockwise)
3. Gentle marching on spot
4. Slow-paced walking in corridor- total-35mins |
| Intervention |
VR Assisted exercises |
Virtual reality (VR) technology immerses patients in a computer-generated environment that closely resembles the real world, enabling interactive experiences- 20 min
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Widespread Pain Index more than or equal to 7 and Symptom Severity Score more than or equal to 5
2. Generalized pain present in more than or equal to 4 of 5 regions: left upper, right upper, left lower, right lower, axial
3. Symptoms present at a similar level for more than or equal to 3 months
4. Pain intensity: more than or equal to 5 on the Visual Analogue Scale at baseline
5. age of 25- 35 years
6. Physical activity status: Sedentary lifestyle- no structured exercise or irregular physical activity in the last 6 months |
|
| ExclusionCriteria |
| Details |
1. Co-morbid autoimmune disorders
2. Serious medical illness, cognitive impairment, psychosis, suicidality, or recent alcohol/drug dependence
3. Surgery of the spine, vertebral fractures, sciatic pain, tumors
4. Previous myocardial infarction, lower extremity arterial disease, major neurological problems, diabetes, gastrointestinal disease, chronic respiratory disease, kidney disease |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.VAS
2.Pressure algometer
3. Penn Computerized Neurocognitive Battery
4.Hospital Anxiety and Depression Scale (HADS)
|
4 weeks, 3 times per week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
NEED OF THE STUDY- Although exercise and mind–body therapies each demonstrate benefits in fibromyalgia, existing evidence is limited by heterogeneous protocols, small sample sizes, and short follow-ups. Virtual reality–assisted exercise enhances engagement and reduces pain, fatigue, and disability, while guided imagery modulates central sensitization and psychological distress. Yet, no high-quality randomized trial has tested whether combining these approaches provides additive or synergistic benefits beyond conventional physiotherapy. This study is therefore needed to evaluate whether the integration of guided imagery with virtual reality–assisted exercise, delivered in a standardized physiotherapy program, produces superior improvements in pain, functional capacity, psychological outcomes, and quality of life compared to conventional physiotherapy alone, thereby filling a critical gap in non-pharmacological fibromyalgia rehabilitation research.
SIGNIFICANCE- Fibromyalgia is a chronic condition marked by widespread pain, hypersensitivity, and multiple somatic symptoms. Evidence shows that guided imagery can reduce pain, improve mood, and enhance quality of life, while exercise effectively improves balance and neuromuscular control. Although both virtual reality (VR) and guided imagery have been studied individually in fibromyalgia, no randomized controlled trial has evaluated their combined effects—particularly in young Indian populations. This study addresses this gap by examining whether integrating guided imagery with a VR-assisted exercise program enhances rehabilitation outcomes in fibromyalgia. |