Adhesive CapsulitisNCT06407817
Comparative Effects Of Spencer and Reverse Distraction Technique In Patients With Adhesive Capsulitis
A study testing Spencer technique and reverse distraction technique in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of spencer and reverse distraction technique in patients with adhesive capsulitis Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Spencer technique and reverse distraction technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 40-60 years
- Male and female
- Positive Capsular pattern (ER more limited than Abd which is more limited than IR)
- Limitation in shoulder ROM ; Flexion <180 , Abduction <180 , External Rotation <50
- Patients of stage 2 and 3 of adhesive capsulitis
Who cannot join
- History of surgery of the affected shoulder
- Fractures in around the shoulder
- Neurological disorders leading to altered muscle activity
- Systemic arthritic conditions (RA, Osteoporosis)
- Disorders of the cervical spine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Johar Pain Relief Center
Lahore, Punjab Province, 54782
Rabiya Noor, Phd, 03344355660, rabiya.noor@riphah.edu.pk
Minal Mushtaq, MS(OMPT)
About this study
To compare the effects of spencer and reverse distraction technique in patients with adhesive capsulitis
Read the detailed description
Adhesive capsulitis, also known as frozen shoulder, is an inflammatory condition characterized by shoulder stiffness, pain, and significant loss of passive range of motion. Adhesive capsulitis has a prevalence of approximately 2% to 5% in the general population, with a mean onset of age of 55.
A randomized clinical trial will be conducted at Ibne Sina Hospital, Multan . Non probability convenience sampling technique will be applied on 50 patients who will be allocated through computerized randomization into group A \& group B to collect data. Group A will be given spencer technique and group B will be given reverse distraction technique along with baselines. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, function, muscle strength, disability and quality of life will be measured pre and post intervention. The whole treatment protocols will be given for four weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Adhesive Capsulitis
- Being tested
- Spencer technique, reverse distraction technique
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spencer techniqueProcedure or surgery
No of repetitions; 3 sets for 10 repetitions with 1 minute rest between sets No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min per Session)
reverse distraction techniqueProcedure or surgery
No of repetitions; 10 ( Shoulder Abduction)10 ( Shoulder Flexion) 10 (Shoulder External Rotation) No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min Per Session)
| Study group | Role | What they receive |
|---|---|---|
| Spencer's technique | Experimental | This group will receive the Spencer's technique. Receives: Procedure: Spencer technique; Procedure: reverse distraction technique |
| reverse distraction technique | Active comparator | This group will recieve reverse distraction technique Receives: Procedure: Spencer technique; Procedure: reverse distraction technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain : numerical pain rating scale
Patients' overall assessment of pain will be provided using the numeric pain rating scale (NPRS). The NPRS is known to be a sensitive and reliable scale for clinical and experimental evaluation of pain intensity. The score ranges from 0, indicating no pain, to 10, expressing worst imaginable pain. The reliability of numeric pain rating scale (NPRS) is 0.92 (0.87, 0.95).
Measured: 6 weeks
range of motion : universal goniometer
Universal Goniometer is the most commonly utilised clinical tool for measuring joint range of motion due to its ease of use, low cost, and demonstrated reasonable levels of reliability and validity in numerous studies. Validity and intertester reliability (r =.97-.98; ICC =.98-.99) are both high
Measured: 6 weeks
shoulder pain and impairment : SPADI
The SPADI consists of 13 items that assess two domains: a 5-item subscale for pain and an 8-item subscale for disability. The SPADI has since been used in both primary care on mixed diagnosis and surgical patient populations including rotator cuff disease, osteoarthritis, and rheumatoid arthritis, adhesive capsulitis ,joint replacement surgery , and in a large population-based study of shoulder symptoms (37).
Reliability- 0.89, Validity - 0.90
Measured: 6 weeks
36-Item Short Form Health Survey questionnaire (SF-36)
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The ICC for SF-36 PF is (0.96, 95% CI 0.92-0.98) so it's a reliable test.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Feb 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407817
- Sponsor's protocol ID
- REC/RCR&AHS/23/0184
- Status last verified
- Dec 2024
- First submitted
- 6 May 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Spencer and Reverse Distraction Technique In Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06407817
- Acronym / sponsor ID
- REC/RCR&AHS/23/0184
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 9 May 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.
To compare the effects of spencer and reverse distraction technique in patients with adhesive capsulitis
Detailed description
Adhesive capsulitis, also known as frozen shoulder, is an inflammatory condition characterized by shoulder stiffness, pain, and significant loss of passive range of motion. Adhesive capsulitis has a prevalence of approximately 2% to 5% in the general population, with a mean onset of age of 55.
A randomized clinical trial will be conducted at Ibne Sina Hospital, Multan . Non probability convenience sampling technique will be applied on 50 patients who will be allocated through computerized randomization into group A \& group B to collect data. Group A will be given spencer technique and group B will be given reverse distraction technique along with baselines. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, function, muscle strength, disability and quality of life will be measured pre and post intervention. The whole treatment protocols will be given for four weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spencer's technique | Experimental | Procedure: Spencer technique, Procedure: reverse distraction techniqueThis group will receive the Spencer's technique. |
| reverse distraction technique | Active comparator | Procedure: Spencer technique, Procedure: reverse distraction techniqueThis group will recieve reverse distraction technique |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group 40-60 years
- Male and female
- Positive Capsular pattern (ER more limited than Abd which is more limited than IR)
- Limitation in shoulder ROM ; Flexion <180 , Abduction <180 , External Rotation <50
- Patients of stage 2 and 3 of adhesive capsulitis
Key exclusion criteria (5 listed)
- History of surgery of the affected shoulder
- Fractures in around the shoulder
- Neurological disorders leading to altered muscle activity
- Systemic arthritic conditions (RA, Osteoporosis)
- Disorders of the cervical spine
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 |
|---|---|---|
| Spencer techniqueNo of repetitions; 3 sets for 10 repetitions with 1 minute rest between sets No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min per Session) | Procedure or surgery | Spencer's technique, reverse distraction technique |
| reverse distraction techniqueNo of repetitions; 10 ( Shoulder Abduction)10 ( Shoulder Flexion) 10 (Shoulder External Rotation) No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min Per Session) | Procedure or surgery | Spencer's technique, reverse distraction technique |
Primary outcome
pain : numerical pain rating scale
Time frame: 6 weeks
Patients' overall assessment of pain will be provided using the numeric pain rating scale (NPRS). The NPRS is known to be a sensitive and reliable scale for clinical and experimental evaluation of pain intensity. The score ranges from 0, indicating no pain, to 10, expressing worst imaginable pain. The reliability of numeric pain rating scale (NPRS) is 0.92 (0.87, 0.95).
range of motion : universal goniometer
Time frame: 6 weeks
Universal Goniometer is the most commonly utilised clinical tool for measuring joint range of motion due to its ease of use, low cost, and demonstrated reasonable levels of reliability and validity in numerous studies. Validity and intertester reliability (r =.97-.98; ICC =.98-.99) are both high
shoulder pain and impairment : SPADI
Time frame: 6 weeks
The SPADI consists of 13 items that assess two domains: a 5-item subscale for pain and an 8-item subscale for disability. The SPADI has since been used in both primary care on mixed diagnosis and surgical patient populations including rotator cuff disease, osteoarthritis, and rheumatoid arthritis, adhesive capsulitis ,joint replacement surgery , and in a large population-based study of shoulder symptoms (37). Reliability- 0.89, Validity - 0.90
36-Item Short Form Health Survey questionnaire (SF-36)
Time frame: 6 weeks
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The ICC for SF-36 PF is (0.96, 95% CI 0.92-0.98) so it's a reliable test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
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OMT for Adhesive Capsulitis
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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.
Rabiya Noor, PHD 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 Spencer technique and reverse distraction technique in people with Adhesive Capsulitis, 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minal Mushtaq, MS-DPT (03314662231, minalmustafakhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain : numerical pain rating scale (time frame: 6 weeks). 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?
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 27 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.