Deep Gluteal SyndromeNCT06197516
Comparison Of INIT Versus NMR in Patients With Deep Gluteal Syndrome
A study testing Integrated Neuromuscular Inhibition Technique and Neuromuscular Reeducation Technique in people with Deep Gluteal Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Rationale of this research is to evaluate the outcome of Comparison of Integrated Neuromuscular Inhibition technique versus Neuromuscular reeducation on pain in patients with Deep Gluteal Syndrome. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Deep Gluteal Syndrome
- What is being tested?
- Integrated Neuromuscular Inhibition Technique and Neuromuscular Reeducation Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders Age: 30-50 years Pain due to a non-discogenic sciatic nerve entrapment in the sub gluteal space Pain, tightness and dysesthesias in the buttock area, posterior thigh Buttock pain aggravated with prolong sitting (\>20-30 min) Buttock pain aggravated when sitting with limited straight leg raising ability (seated piriformis test) Pain with the passive internal rotation of hip (Freiberg sign) Pain increase in Flexion, Adduction and internal rotation (Positive FAIR test)
Who cannot join
- Patient with any Intrinsic Etiology such as hemarthrosis, rheumatoid arthritis, infection or gout Patient with any severe trauma, fractures dislocation, subluxation or ligament injury Any pathology or recent injury around the hip, sacroiliac joint, or lumbar spine Limb length discrepancy Recent buttock trauma and bladder/bowel dysfunction
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gulberg green campus of Riphah International University
Islamabad, Punjab Province, 44000
About this study
Official title: Comparison Of Integrated Neuromuscular Inhibition Technique Versus Neuromuscular Reeducation in Patients With Deep Gluteal Syndrome
Rationale of this research is to evaluate the outcome of Comparison of Integrated Neuromuscular Inhibition technique versus Neuromuscular reeducation on pain in patients with Deep Gluteal Syndrome. The significance of this study is to identify which technique is superior in alleviating the symptoms of deep gluteal syndrome. This study will help gather evidence on the practice of incorporating trigger point therapy in the treatment of deep gluteal syndrome.
Read the detailed description
Deep gluteal syndrome is a common buttock and posterior hip pain caused by entrapment of the sciatic nerve in the posterior hip region. Nonoperative therapy involves treating the entrapment location, using rest, anti-inflammatories, musclerelaxants, and physical therapy to relieve compression. The purpose of the study was to evaluate the effects of Integrated Neuromuscular Inhibition Technique versus Neuromuscular Reeducation Technique on pain in subject with deep gluteal syndrome. It was a randomized, controlled trial, conducted among deep gluteal syndrome patients. Sample size was 54 by using G Power Tool software. Participantswere randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope. All participants in both groups were evaluated on baseline and 12 th Session.
- Conditions
- Deep Gluteal Syndrome
- Being tested
- Integrated Neuromuscular Inhibition Technique, Neuromuscular Reeducation Technique
- Keywords
- Trigger point, NMR, INIT, Deep Gluteal Syndrome
- Medical subject headings
- Hip socket neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Neuromuscular Inhibition TechniqueOther
After palpating the trigger point ischemic compression were applied for 20-60 sec while strain Counterstain for 60-90 sec and MET is for 7-10 sec.
Neuromuscular Reeducation TechniqueOther
Deep pressure were applied along origin and insertion of Piriformis and hamstring muscle combined with active movement of patient for 5 -15 time as per required
| Study group | Role | What they receive |
|---|---|---|
| Integrated Neuromuscular Inhibition Technique | Experimental | Individuals in Group A, After palpating the trigger point ischemic compression were applied for 20-60 sec while strain counterstain for 60-90 sec and MET is for 7-10 sec. This technique was repeat 3-4 time per session Conventional treatment include Hot Pack for 5mins, AROM exercises ,Home plans include stretching exercise of glutes,hamstring and calf (5-7 reps x 10 sec hold, each). Receives: Other: Integrated Neuromuscular Inhibition Technique |
| Neuromuscular Reeducation Technique | Active comparator | Deep pressure were applied along origin and insertion of Piriformis and hamstring muscle combined with active movement of patient for 5 -15 time as per required (depend upon thickness of scar) per session, 10 sec rest b/w pressure. This technique given 5 time per session. Conventional treatment include Hot Pack for 5mins, AROM exercises ,Home plans include stretching exercise of glutes,hamstring and calf (5-7 reps x 10 sec hold, each). Receives: Other: Neuromuscular Reeducation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Numeric Pain Rate Scale used to assess pain intensity
Measured: 4th week
Goniometer
used to assess lower limb ranges
Measured: 4th week
Lower Extremity Functional scale
LEFS questionnaire have 20 questions will assess the impairment of a patient with lower extremity musculoskeletal condition or disorders
Measured: 4th week
Sciatica Bothersomeness Index
used to measure the participants' level of sciatica. The scale's ratings range from 0 to 24, with higher levels indicating severe sciatica discomfort.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start10 Apr 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep Gluteal SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramsha Tariq, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197516
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/01
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aguilera-Bohorquez B, Cardozo O, Brugiatti M, Cantor E, Valdivia N. Endoscopic treatment of sciatic nerve entrapment in deep gluteal syndrome: Clinical results. Rev Esp Cir Ortop Traumatol (Engl Ed). 2018 Sep-Oct;62(5):322-327. doi: 10.1016/j.recot.2018.03.004. Epub 2018 May 26. English, Spanish.
PubMed 29807785Frank RM, Slabaugh MA, Grumet RC, Virkus WW, Bush-Joseph CA, Nho SJ. Posterior hip pain in an athletic population: differential diagnosis and treatment options. Sports Health. 2010 May;2(3):237-46. doi: 10.1177/1941738110366000.
PubMed 23015944Boyajian-O'Neill LA, McClain RL, Coleman MK, Thomas PP. Diagnosis and management of piriformis syndrome: an osteopathic approach. J Am Osteopath Assoc. 2008 Nov;108(11):657-64. doi: 10.7556/jaoa.2008.108.11.657.
PubMed 19011229
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Integrated Neuromuscular Inhibition Technique Versus Neuromuscular Reeducation in Patients With Deep Gluteal Syndrome
- ClinicalTrials.gov ID
- NCT06197516
- Acronym / sponsor ID
- RCRAHS-ISB/REC/MS-PT/01
- Conditions
- Deep Gluteal Syndrome
- Keywords
- Trigger point, NMR, INIT, Deep Gluteal Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale of this research is to evaluate the outcome of Comparison of Integrated Neuromuscular Inhibition technique versus Neuromuscular reeducation on pain in patients with Deep Gluteal Syndrome. The significance of this study is to identify which technique is superior in alleviating the symptoms of deep gluteal syndrome. This study will help gather evidence on the practice of incorporating trigger point therapy in the treatment of deep gluteal syndrome.
Detailed description
Deep gluteal syndrome is a common buttock and posterior hip pain caused by entrapment of the sciatic nerve in the posterior hip region. Nonoperative therapy involves treating the entrapment location, using rest, anti-inflammatories, musclerelaxants, and physical therapy to relieve compression. The purpose of the study was to evaluate the effects of Integrated Neuromuscular Inhibition Technique versus Neuromuscular Reeducation Technique on pain in subject with deep gluteal syndrome. It was a randomized, controlled trial, conducted among deep gluteal syndrome patients. Sample size was 54 by using G Power Tool software. Participantswere randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope. All participants in both groups were evaluated on baseline and 12 th Session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Neuromuscular Inhibition Technique | Experimental | Other: Integrated Neuromuscular Inhibition TechniqueIndividuals in Group A, After palpating the trigger point ischemic compression were applied for 20-60 sec while strain counterstain for 60-90 sec and MET is for 7-10 sec. This technique was repeat 3-4 time per session Conventional treatment include Hot Pack for 5mins, AROM exercises ,Home plans include stretching exercise of glutes,hamstring and calf (5-7 reps x 10 sec hold, each). |
| Neuromuscular Reeducation Technique | Active comparator | Other: Neuromuscular Reeducation TechniqueDeep pressure were applied along origin and insertion of Piriformis and hamstring muscle combined with active movement of patient for 5 -15 time as per required (depend upon thickness of scar) per session, 10 sec rest b/w pressure. This technique given 5 time per session. Conventional treatment include Hot Pack for 5mins, AROM exercises ,Home plans include stretching exercise of glutes,hamstring and calf (5-7 reps x 10 sec hold, each). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Both genders Age: 30-50 years Pain due to a non-discogenic sciatic nerve entrapment in the sub gluteal space Pain, tightness and dysesthesias in the buttock area, posterior thigh Buttock pain aggravated with prolong sitting (\>20-30 min) Buttock pain aggravated when sitting with limited straight leg raising ability (seated piriformis test) Pain with the passive internal rotation of hip (Freiberg sign) Pain increase in Flexion, Adduction and internal rotation (Positive FAIR test)
Key exclusion criteria (1 listed)
- Patient with any Intrinsic Etiology such as hemarthrosis, rheumatoid arthritis, infection or gout Patient with any severe trauma, fractures dislocation, subluxation or ligament injury Any pathology or recent injury around the hip, sacroiliac joint, or lumbar spine Limb length discrepancy Recent buttock trauma and bladder/bowel dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Neuromuscular Inhibition TechniqueAfter palpating the trigger point ischemic compression were applied for 20-60 sec while strain Counterstain for 60-90 sec and MET is for 7-10 sec. | Other | Integrated Neuromuscular Inhibition Technique |
| Neuromuscular Reeducation TechniqueDeep pressure were applied along origin and insertion of Piriformis and hamstring muscle combined with active movement of patient for 5 -15 time as per required | Other | Neuromuscular Reeducation Technique |
Primary outcome
NPRS
Time frame: 4th week
Numeric Pain Rate Scale used to assess pain intensity
Goniometer
Time frame: 4th week
used to assess lower limb ranges
Lower Extremity Functional scale
Time frame: 4th week
LEFS questionnaire have 20 questions will assess the impairment of a patient with lower extremity musculoskeletal condition or disorders
Sciatica Bothersomeness Index
Time frame: 4th week
used to measure the participants' level of sciatica. The scale's ratings range from 0 to 24, with higher levels indicating severe sciatica discomfort.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 29807785Aguilera-Bohorquez B, Cardozo O, Brugiatti M, Cantor E, Valdivia N. Endoscopic treatment of sciatic nerve entrapment in deep gluteal syndrome: Clinical results. Rev Esp Cir Ortop Traumatol (Engl Ed). 2018 Sep-Oct;62(5):322-327. doi: 10.1016/j.recot.2018.03.004. Epub 2018 May 26. English, Spanish.
- Background: PubMed 23015944Frank RM, Slabaugh MA, Grumet RC, Virkus WW, Bush-Joseph CA, Nho SJ. Posterior hip pain in an athletic population: differential diagnosis and treatment options. Sports Health. 2010 May;2(3):237-46. doi: 10.1177/1941738110366000.
- Background: PubMed 19011229Boyajian-O'Neill LA, McClain RL, Coleman MK, Thomas PP. Diagnosis and management of piriformis syndrome: an osteopathic approach. J Am Osteopath Assoc. 2008 Nov;108(11):657-64. doi: 10.7556/jaoa.2008.108.11.657.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramsha Tariq, MS-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Neuromuscular Inhibition Technique and Neuromuscular Reeducation Technique in people with Deep Gluteal Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS (time frame: 4th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197516, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.