Sacroiliac; Sprain (Strain)NCT05076136
Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain
A study testing Regional treatment and Standard physiotherapy treatment in people with Sacroiliac; Sprain (Strain), run by Riphah International University at 1 site in Pakistan.
Trial summary
The SIJ has long been considered an important source of low back pain because of the empirical finding that treatment targeting the SIJ can relieve pain.This study was be a Randomized Clinical Trail conducted at Riphah Rehabilitation Centre Lahore. The study was be completed within the time duration of Six months. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Sacroiliac; Sprain (Strain)
- What is being tested?
- Regional treatment and Standard physiotherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Nov 2019to 10 Nov 2020
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with sacroiliac joint pain
- Age: 20 to 50 years
Who cannot join
- Patients withany red flag signs i.etumor, fracture, metabolic diseases, rheumatoid arthritis, prolonged history of steroids use, etc.
- Females with sciatica
- Females with radiating pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain.
The SIJ has long been considered an important source of low back pain because of the empirical finding that treatment targeting the SIJ can relieve pain.This study was be a Randomized Clinical Trail conducted at Riphah Rehabilitation Centre Lahore. The study was be completed within the time duration of Six months. Purposive sampling technique was be used. Sample size is calculated by using the G power 3.1. The sample size of 64 patients was be taken in this study to find the comparison of regional manual therapy and standard physiotherapy intervention in females with sacroiliac joint pain. Patients was be divided into two groups.. Patients was be divided into two groups. Group A was be treated with regional manual therapy. In regional manual therapy patients was be given mobilization to lumber region and SIJ, pelvic floor exercises and core strengthening exercises and Group B was be treated with standard physiotherapy in which patients was be given SIJ mobilization and Straight leg raise. Both groups was receive transcutaneous electrical nerve stimulator and heating pad as a common treatment protocol. Numeric pain rating scale (NPRS) and oswestry low back disability questionnaire was be used as Data collecting tools. Two session of treatment per week for eight weeks was be given. Data was be analyzed on SPSS 21.
- Conditions
- Sacroiliac; Sprain (Strain)
- Being tested
- Regional treatment, Standard physiotherapy treatment
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional treatmentOther
In reginal treatment patients were given physiotherapy exercises and manual therapies on hip joint as well as on surrounding areas of hip joint such as lumber area and sacroiliac joint.
Standard physiotherapy treatmentOther
In this treatment patients were given just hip joint mobilizations and quadriceps and hamstrings stretching.
| Study group | Role | What they receive |
|---|---|---|
| Regional treatment | Experimental | Group A was given regional treatment with baseline treatment protocol Receives: Other: Regional treatment |
| Standard physiotherapy treatment | Active comparator | Group B was given standard physiotherapy treatment with baseline protocol Receives: Other: Standard physiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
Measured: Eight week
Oswestry low back disability questionnaire
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Measured: Eight week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start24 Nov 2019
- Primary completion10 Oct 2020
- Study completion10 Nov 2020
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 Sacroiliac; Sprain (Strain)Studies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tasneem Shahzadi, Mphil, Study chair, Riphah international university Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076136
- Sponsor's protocol ID
- REC/RCRS/20/1017
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forst SL, Wheeler MT, Fortin JD, Vilensky JA. The sacroiliac joint: anatomy, physiology and clinical significance. Pain Physician. 2006 Jan;9(1):61-7.
PubMed 167002835. Merskey H, Bogduk N. Classification of Chronic Pain:Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. 2nd ed. Seattle, WA: IASP Press; 1994.
Fortin JD, Dwyer AP, West S, Pier J. Sacroiliac joint: pain referral maps upon applying a new injection/arthrography technique. Part I: Asymptomatic volunteers. Spine (Phila Pa 1976). 1994 Jul 1;19(13):1475-82.
PubMed 7939978
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain.
- ClinicalTrials.gov ID
- NCT05076136
- Acronym / sponsor ID
- REC/RCRS/20/1017
- Conditions
- Sacroiliac; Sprain (Strain)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Nov 2019 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 13 Oct 2021 (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.
The SIJ has long been considered an important source of low back pain because of the empirical finding that treatment targeting the SIJ can relieve pain.This study was be a Randomized Clinical Trail conducted at Riphah Rehabilitation Centre Lahore. The study was be completed within the time duration of Six months. Purposive sampling technique was be used. Sample size is calculated by using the G power 3.1. The sample size of 64 patients was be taken in this study to find the comparison of regional manual therapy and standard physiotherapy intervention in females with sacroiliac joint pain. Patients was be divided into two groups.. Patients was be divided into two groups. Group A was be treated with regional manual therapy. In regional manual therapy patients was be given mobilization to lumber region and SIJ, pelvic floor exercises and core strengthening exercises and Group B was be treated with standard physiotherapy in which patients was be given SIJ mobilization and Straight leg raise. Both groups was receive transcutaneous electrical nerve stimulator and heating pad as a common treatment protocol. Numeric pain rating scale (NPRS) and oswestry low back disability questionnaire was be used as Data collecting tools. Two session of treatment per week for eight weeks was be given. Data was be analyzed on SPSS 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional treatment | Experimental | Other: Regional treatmentGroup A was given regional treatment with baseline treatment protocol |
| Standard physiotherapy treatment | Active comparator | Other: Standard physiotherapy treatmentGroup B was given standard physiotherapy treatment with baseline protocol |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females with sacroiliac joint pain
- Age: 20 to 50 years
Key exclusion criteria (3 listed)
- Patients withany red flag signs i.etumor, fracture, metabolic diseases, rheumatoid arthritis, prolonged history of steroids use, etc.
- Females with sciatica
- Females with radiating pain
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 |
|---|---|---|
| Regional treatmentIn reginal treatment patients were given physiotherapy exercises and manual therapies on hip joint as well as on surrounding areas of hip joint such as lumber area and sacroiliac joint. | Other | Regional treatment |
| Standard physiotherapy treatmentIn this treatment patients were given just hip joint mobilizations and quadriceps and hamstrings stretching. | Other | Standard physiotherapy treatment |
Primary outcome
NPRS
Time frame: Eight week
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
Oswestry low back disability questionnaire
Time frame: Eight week
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
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 13 Oct 2021.
- Background: PubMed 16700283Forst SL, Wheeler MT, Fortin JD, Vilensky JA. The sacroiliac joint: anatomy, physiology and clinical significance. Pain Physician. 2006 Jan;9(1):61-7.
- Background5. Merskey H, Bogduk N. Classification of Chronic Pain:Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. 2nd ed. Seattle, WA: IASP Press; 1994.
- Background: PubMed 7939978Fortin JD, Dwyer AP, West S, Pier J. Sacroiliac joint: pain referral maps upon applying a new injection/arthrography technique. Part I: Asymptomatic volunteers. Spine (Phila Pa 1976). 1994 Jul 1;19(13):1475-82.
- Individual participant dataSharing planned: No
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.
Tasneem Shahzadi, Mphil study chair
Riphah international university Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional treatment and Standard physiotherapy treatment in people with Sacroiliac; Sprain (Strain), 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 2 inclusion and 3 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 13 Oct 2021. 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: Eight week). The study lists 2 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 NCT05076136, 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 13 Oct 2021.