| CTRI Number |
CTRI/2025/05/086798 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effectiveness of Dynamic cupping and IASTM on Pain, Range of Motion, Disability, Function
in piriformis syndrome: Three arm parallel study. |
|
Scientific Title of Study
|
Effectiveness of Dynamic cupping and IASTM on Pain, Range of Motion, Disability, Function
in piriformis syndrome: Three arm parallel study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Deshmukh |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institude of Higher education and Research Center. |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College OPD, Datta Meghe Institude of Higher education and Research Center.
Wardha
MAHARASHTRA
442001
India |
| Phone |
09561950640 |
| Fax |
|
| Email |
nikitadesh09@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghuveer Raghumahanti |
| Designation |
Professor and HOD |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institude of Higher education and Research. |
| Address |
Department of NeuroPhysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institude of Higher education and Research.
Wardha
MAHARASHTRA
442001
India |
| Phone |
08126506769 |
| Fax |
|
| Email |
raghuveer.raghumahanti@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Raghuveer Raghumahanti |
| Designation |
Professor and HOD |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institude of Higher education and Research. |
| Address |
Department of NeuroPhysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institude of Higher education and Research.
Wardha
MAHARASHTRA
442001
India |
| Phone |
08126506769 |
| Fax |
|
| Email |
raghuveer.raghumahanti@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| RNPC,AVBRH Hospital and Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha. |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institude of Higher Education and Research Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha-442001, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Nikita Deshmukh |
Acharya Vinoba Bhave Rural Hospital OPD |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha.
Wardha
MAHARASHTRA |
09561950640
nikitadesh09@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee DMIHER(DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL THERAPY |
Piriformis, hip flexors, hamstrings, and gluteal muscles, hip adductor, hip abductor, external rotator stretching for 10 min.,
Moist Heat therapy for buttock and posterior thigh for 8 min.,
Strengthening exercises core muscles, gluteals, hip flexors, hamstrings, hip adductor, hip abductor, external rotator and 10min
|
| Intervention |
Dynamic cupping |
Select an appropriate cup size based on the treatment area (medium to large for the glutes and lower back). Place the cup over the targeted region, such as the gluteal area where the piriformis muscle lies. Create suction by squeezing the silicone cup or using a vacuum pump. Once suction is established, gently glide the cup over the treatment area. Focus on the following regions:
o Gluteal area (piriformis, gluteus maximus/medius).
o Posterior thigh (hamstring attachments if indicated).
Move the cup longitudinally along muscle fibers or in circular/spiral patterns. Avoid abrupt or jerky movements to ensure patient comfort. Perform dynamic cupping for 5–10 minutes per session. Monitor the skin for redness or irritation; this is expected but should not cause discomfort.
|
| Comparator Agent |
IASTM |
Perform light, sweeping strokes across the gluteal region with the tool to locate tissue irregularities, tightness, or adhesions. Focus on the area from the sacrum to the greater trochanter and along the sciatic nerve pathway.
Longitudinal Strokes (with Muscle Fibers):
Apply moderate pressure with the tool along the length of the piriformis muscle. Use strokes from the sacrum toward the greater trochanter and posterior thigh, posterior leg and planter fascia. Perform for 1–2 minutes, adjusting the pressure based on patient feedback.
Cross-Fiber Strokes (against Muscle Fibers): Use short, perpendicular strokes to address adhesions and scar tissue. Focus on specific tight spots while avoiding excessive pressure over the sciatic nerve. Perform for 30–60 seconds at each tender point.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Tenderness in PS muscle
2. positive FAIR test |
|
| ExclusionCriteria |
| Details |
1. Any history of trauma and injury
2. History of surgery.
3. Individual having tenderness not because of piriformis syndrome.
4. Pain in buttock not because of piriformis syndrome.
5. Diagnosed cases of rheumatoid arthritis or osteoarthritis of the spine or hips.
6. Iliotibial band tightness.
7. Capsulitis.
8. Those undertaking an active exercise programmed for back, buttock, or hip pain at present
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Modified FAIR test and Piriformis muscle tightness measurement.
2. Visual Analogue Score
3. Lower Extremity Functional Scale (LEFS) |
Modified FAIR test and Piriformis muscle tightness measurement before the intervention and after the three week
2. Visual Analogue Score
3. Lower Extremity Functional Scale (LEFS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Goniometer |
The outcome assessed pre intervention i.e. on 1st day and post intervention i.e. on 3rd week |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
19/07/2025 |
| 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="1"
Months="0"
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
|
Piriformis syndrome is a type of sciatica caused by
compression of the nerve by the piriformis muscle. This triangular, flattened
muscle extends between the sacrum and the greater trochanter, starting from the
pelvic surface of the sacral bone. It runs laterally through the greater
sciatic foramen and ends with a tendon on the medial side of the greater
trochanter of the femur. It is one of the six short muscles of the external
rotators group. Piriformis Syndrome is more common in women than men, possibly
because of biomechanics associated with the wider quadriceps femoris muscle
angle (i.e., “Q angle”) in the os coxae (pelvis) of women. Barr’s work
correlating clinical features with operative and histological findings, the
dominant opinion for decades on the cause of sciatica was nerve root
compression by a herniated intervertebral disc. An alternative cause,
compression of the nerve trunk by the piriformis muscle, was proposed by
Freiberg and Vinke and developed by Robinson, who is credited with coining the
term Piriformis Syndrome. Aim is To find
the effectiveness of Dynamic cupping and IASTM
on Pain, Range of Motion, Disability,
Function in piriformis syndrome. pre assessment
will be taken with the consent form from group A, B, C ie. Dynamic cupping
IASTM and conventional Physiotherapy for 75 participant in three groups for 3
weeks after the treatment post assessment will be taken from VAS, LEFS. |