Sacroiliac Joint DysfunctionNCT06656208
Effects of Pubic Symphysis Manipulation in Patients With Sacroiliac Joint Dysfunction
A study testing Pubic symphysis manipulation and Traditional sacroiliac treatment in people with Sacroiliac Joint Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to determine the effect of Pubic Symphysis manipulation on pain, disability and fear avoidance behavior in patients with sacroiliac joint dysfunction. Randomized controlled trials was done at Pakistan Railway Hospital. The sample size was 44. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Pubic symphysis manipulation and Traditional sacroiliac treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2024to 16 Apr 2025
- 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 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female gender
- Age 25-60 years
- Presence of back pain for ≥6 months
- Postpartum women
- Patient with pubic tenderness
- Patient with pubic symphysis asymmetry
- Unilateral back pain
- Participants had 2 positive test out of four test, Sacroiliac distraction test, Sacroiliac compression test, thigh thrust test, sacral thrust test.
Who cannot join
- Participants underwent surgical approaches
- History of fracture
- Patients suffering from pubic neuralgia and osteitis pubis
- SIJ or Hip joint pathology
- Arthritides
- Adductor strain
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research is to determine the effect of Pubic Symphysis manipulation on pain, disability and fear avoidance behavior in patients with sacroiliac joint dysfunction. Randomized controlled trials was done at Pakistan Railway Hospital. The sample size was 44. The subjects will be divided into Control group and Experimental group. Each group will be having 22 participants. Study duration was of 12 months. Sampling technique applied was non probability connivance sampling technique. Subject included in the study will be female with presence of back pain for ≥6 months, Unilateral back pain, Age 25-60 years, Postpartum women, Patient with pubic tenderness. Tools used in the study are NPRS, Oswestry Disability Index and FABQ. Data will be analyzed using SPSS version 26.
Read the detailed description
Sacroiliac joint (SIJ) dysfunction is a degenerative condition that is considered a major cause of low back pain. It has been resulting from abnormal motion of the joint known as SIJ dysfunction (SIJD). During pregnancy, heightened levels of estrogen and relaxin, coupled with the pressure exerted by a growing fetus, may induce excessive mobility in the SIJs. Conversely, pelvic fractures and a sedentary lifestyle can contribute to decreased mobility and fixation of the joints. Life time prevalence of low back pain is 85%. Among these patients 10% to 25% of, sacroiliac joint is the cause of pain. In Pakistan, female undergraduate students have a higher prevalence of low back pain compared to males. Individuals with SIJD often present with unilateral pain below L5. The pain is often localized distal and medial to the PSIS. It is described as sharp, dull, or shooting and is often misdiagnosed as radicular pain, as it can extend down the posterior thigh to the S1 dermatome. Factors contributing to SIJD include high velocity trauma, degenerative arthritis, inflammatory arthropathy etc. The ability to rise from a chair is a basic functional task that is frequently compromised in individuals diagnosed with SIJD. This condition has been associated with up to 14-20% of patients affected by limiting the overall quality of life.
The pubic symphysis plays a vital role in stabilizing the anterior pelvis while allowing for a limited range of movement. Pubic symphysis dysfunction is characterized by discomfort in the pubic bone region that intensifies during activities such as walking, lifting, or stair climbing, hip abduction, rolling over in bed. Patients often report tenderness over the pubic symphysis. Symptoms include burning, stabbing, or shooting pain that radiates towards the abdomen, back, leg, and perineum. Symphysis pubis dysfunction (SPD) occurs where the joint becomes sufficiently relaxed to allow instability in the pelvic girdle. In severe cases of SPD the symphysis pubis may partially or completely rupture.
Literature review: A study by Aghalar Javadov et al. in 2021 aims to assess the effects of manual therapy for sacroiliac joints in comparison with lumbar exercises. Result of this study shows long term effects of manual therapy in sacroiliac joint dysfunction.
Another study conducted by Shokri E et al. in which effectiveness of sacroiliac joint (SIJ) manipulation alone was compared with a combination of SIJ and lumbar manipulation for treating SIJ dysfunction. The study results indicated that a single session of SIJ and lumbar manipulation is more effective in reducing functional disability compared to SIJ manipulation alone.
A study conducted by S. Becker et al. investigates whether sacroiliac joint pain is linked to alterations in the pubic symphysis. The findings of this study indicate that changes in the pubic symphysis, along with low back pain and positive provocative tests, could potentially indicate dysfunction in the sacroiliac joint.
Purpose of the study was to investigate effects of pubic symphysis manipulation in patients with sacroiliac joint dysfunction.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Pubic symphysis manipulation, Traditional sacroiliac treatment
- Keywords
- Sacroiliac joint dysfunction, Symphysis pubis dysfunction (SPD), Pubic symphysis manipulation (PSM), Low back pain, Disability, Pubic malalignment
- Medical subject headings
- Pelvic Girdle Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pubic symphysis manipulationOther
Manipulation was applied in the crook lying position with 5 repetitions hold for 10 sec and ask the patient to apply max. Contraction in Abduction and then relax. Whereas, the therapist applies a rapid stretch to a new barrier and is held for 10 seconds.
Traditional sacroiliac treatmentOther
Mobilization was applied in prone lying position on sacroiliac joint, 30 Oscillations per set for 15 seconds, 3 sets on effected side.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Pubic symphysis manipulation with 5 repetitions hold for 10 sec and ask the patient to apply max. Contraction and then relax. Whereas, the therapist applies a rapid stretch to a new barrier and is held for 10 seconds.
SIJ mobilizations will be given with 30 Oscillations per set for 15 seconds, 3 sets on effected side along with Receives: Other: Pubic symphysis manipulation |
| Control Group | Active comparator | SIJ mobilizations will be given with 30 Oscillations per set for 15 seconds, 3 sets on effected side. Receives: Other: Traditional sacroiliac treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
The NPRS is a self-reported, or clinician administered, measurement tool to measure pain intensity consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain'. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form.
Measured: baseline to 6th day
Fear Avoidance Belief Questionnaire (FABQ)
his scale is used to measure fear avoidance behavior in patients due to pain. It consists of 16 items and patients rate their agreement with each statement on a 7- point Likert scale (0 = completely disagree, 6 = completely agree). The original factor analysis revealed two sub-scales: the work sub-scale (FABQ w) with 7 questions (maximum score = 42) and the physical activity sub-scale (FABQ pa) with 4 questions (maximum score = 24). A higher score indicates more strongly held fear avoidance beliefs.
Measured: baseline to 6th day
Secondary outcomes (1)
Oswestry Disability Index (ODI)
The Oswestry Disability Index is used to measure a patient's permanent functional disability. There are 10 questions, for each question there is a possible 5 points; 0 for the first answer, 1 for the second answer, etc. Add up the total for the 10 questions and rate them on the scale at right. Indicating Mild, Moderate, Severe, Complete or No disability.
Measured: baseline to 6th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start10 Oct 2024
- Primary completion25 Jan 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maliha Fatima, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656208
- Sponsor's protocol ID
- RiphahIUMalihaFatima
- Status last verified
- Apr 2025
- First submitted
- 23 Oct 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pubic Symphysis Manipulation in Patients With Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT06656208
- Acronym / sponsor ID
- RiphahIUMalihaFatima
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- Sacroiliac joint dysfunction, Symphysis pubis dysfunction (SPD), Pubic symphysis manipulation (PSM), Low back pain, Disability, Pubic malalignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 24 Oct 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.
The aim of this research is to determine the effect of Pubic Symphysis manipulation on pain, disability and fear avoidance behavior in patients with sacroiliac joint dysfunction. Randomized controlled trials was done at Pakistan Railway Hospital. The sample size was 44. The subjects will be divided into Control group and Experimental group. Each group will be having 22 participants. Study duration was of 12 months. Sampling technique applied was non probability connivance sampling technique. Subject included in the study will be female with presence of back pain for ≥6 months, Unilateral back pain, Age 25-60 years, Postpartum women, Patient with pubic tenderness. Tools used in the study are NPRS, Oswestry Disability Index and FABQ. Data will be analyzed using SPSS version 26.
Detailed description
Sacroiliac joint (SIJ) dysfunction is a degenerative condition that is considered a major cause of low back pain. It has been resulting from abnormal motion of the joint known as SIJ dysfunction (SIJD). During pregnancy, heightened levels of estrogen and relaxin, coupled with the pressure exerted by a growing fetus, may induce excessive mobility in the SIJs. Conversely, pelvic fractures and a sedentary lifestyle can contribute to decreased mobility and fixation of the joints. Life time prevalence of low back pain is 85%. Among these patients 10% to 25% of, sacroiliac joint is the cause of pain. In Pakistan, female undergraduate students have a higher prevalence of low back pain compared to males. Individuals with SIJD often present with unilateral pain below L5. The pain is often localized distal and medial to the PSIS. It is described as sharp, dull, or shooting and is often misdiagnosed as radicular pain, as it can extend down the posterior thigh to the S1 dermatome. Factors contributing to SIJD include high velocity trauma, degenerative arthritis, inflammatory arthropathy etc. The ability to rise from a chair is a basic functional task that is frequently compromised in individuals diagnosed with SIJD. This condition has been associated with up to 14-20% of patients affected by limiting the overall quality of life.
The pubic symphysis plays a vital role in stabilizing the anterior pelvis while allowing for a limited range of movement. Pubic symphysis dysfunction is characterized by discomfort in the pubic bone region that intensifies during activities such as walking, lifting, or stair climbing, hip abduction, rolling over in bed. Patients often report tenderness over the pubic symphysis. Symptoms include burning, stabbing, or shooting pain that radiates towards the abdomen, back, leg, and perineum. Symphysis pubis dysfunction (SPD) occurs where the joint becomes sufficiently relaxed to allow instability in the pelvic girdle. In severe cases of SPD the symphysis pubis may partially or completely rupture.
Literature review: A study by Aghalar Javadov et al. in 2021 aims to assess the effects of manual therapy for sacroiliac joints in comparison with lumbar exercises. Result of this study shows long term effects of manual therapy in sacroiliac joint dysfunction.
Another study conducted by Shokri E et al. in which effectiveness of sacroiliac joint (SIJ) manipulation alone was compared with a combination of SIJ and lumbar manipulation for treating SIJ dysfunction. The study results indicated that a single session of SIJ and lumbar manipulation is more effective in reducing functional disability compared to SIJ manipulation alone.
A study conducted by S. Becker et al. investigates whether sacroiliac joint pain is linked to alterations in the pubic symphysis. The findings of this study indicate that changes in the pubic symphysis, along with low back pain and positive provocative tests, could potentially indicate dysfunction in the sacroiliac joint.
Purpose of the study was to investigate effects of pubic symphysis manipulation in patients with sacroiliac joint dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Pubic symphysis manipulationPubic symphysis manipulation with 5 repetitions hold for 10 sec and ask the patient to apply max. Contraction and then relax. Whereas, the therapist applies a rapid stretch to a new barrier and is held for 10 seconds. SIJ mobilizations will be given with 30 Oscillations per set for 15 seconds, 3 sets on effected side along with |
| Control Group | Active comparator | Other: Traditional sacroiliac treatmentSIJ mobilizations will be given with 30 Oscillations per set for 15 seconds, 3 sets on effected side. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female gender
- Age 25-60 years
- Presence of back pain for ≥6 months
- Postpartum women
- Patient with pubic tenderness
Key exclusion criteria (6 listed)
- Participants underwent surgical approaches
- History of fracture
- Patients suffering from pubic neuralgia and osteitis pubis
- SIJ or Hip joint pathology
- Arthritides
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 |
|---|---|---|
| Pubic symphysis manipulationManipulation was applied in the crook lying position with 5 repetitions hold for 10 sec and ask the patient to apply max. Contraction in Abduction and then relax. Whereas, the therapist applies a rapid stretch to a new barrier and is held for 10 seconds. | Other | Experimental Group |
| Traditional sacroiliac treatmentMobilization was applied in prone lying position on sacroiliac joint, 30 Oscillations per set for 15 seconds, 3 sets on effected side. | Other | Control Group |
Primary outcome
Numeric pain rating scale
Time frame: baseline to 6th day
The NPRS is a self-reported, or clinician administered, measurement tool to measure pain intensity consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain'. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form.
Fear Avoidance Belief Questionnaire (FABQ)
Time frame: baseline to 6th day
his scale is used to measure fear avoidance behavior in patients due to pain. It consists of 16 items and patients rate their agreement with each statement on a 7- point Likert scale (0 = completely disagree, 6 = completely agree). The original factor analysis revealed two sub-scales: the work sub-scale (FABQ w) with 7 questions (maximum score = 42) and the physical activity sub-scale (FABQ pa) with 4 questions (maximum score = 24). A higher score indicates more strongly held fear avoidance beliefs.
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: baseline to 6th day
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 18 Apr 2025.
- 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.
Maliha Fatima, 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 Pubic symphysis manipulation and Traditional sacroiliac treatment in people with Sacroiliac Joint Dysfunction, 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 8 inclusion and 6 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 18 Apr 2025. 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?
Numeric pain rating scale (time frame: baseline to 6th day). 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?
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 18 Apr 2025.