Adhesive CapsulitisNCT05450068
Effects of Combining Mobilization With Movement and Spencer's Technique in Diabetic Adhesive Capsulitis Patients
A study testing Mulligan's Mobilization with movement, Spencer's muscle energy technique and Conventional Therapy in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be a randomized control trial conducted on 44 patients diagnosed as adhesive capsulitis in headquarter hospital Gujar khan. Subjects will be divided equally into 4 groups (n=11 in each group) that are Group A, B, C and D by sealed envelope method. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Mulligan's Mobilization with movement, Spencer's muscle energy technique and Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2022to 30 Aug 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female
- Age bracket is 30-70 years
- Pain in the shoulder for at least three months
- All active and passive shoulder movements restricted, with a reduction in external rotation of at least 50%.
Who cannot join
- Patients with
- Recent history of surgery on particular shoulder
- Post-traumatic and rotator cuff rupture
- Neurological deficits affecting shoulder function
- Pain or disorders of cervical spine, elbow, wrist or hand
- Tendon calcification
Show all 13Show fewer
- Rheumatoid arthritis
- Osteoporosis
- Malignancies
- Pregnancy
- Open wounds or skin infections
- Recent steroid injection
- Previous manipulation under anesthesia of affected shoulder.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be a randomized control trial conducted on 44 patients diagnosed as adhesive capsulitis in headquarter hospital Gujar khan. Subjects will be divided equally into 4 groups (n=11 in each group) that are Group A, B, C and D by sealed envelope method. Pre-intervention assessment will be done by using data collection tools and then intervention will be applied. Group A will receive mobilization with movement (MWM) technique along with Spencer's muscle energy technique (MET) with conventional therapy. Group B will receive MWM along with conventional therapy. Group C will receive Spencer's MET along with conventional therapy. Group D will receive conventional therapy alone. All subjects will be given a home exercise plan. Assessment will be done after 1st session, 1st week, 2nd week, 3rd week and finally after 2 weeks on follow up using data collection tool. Data collection tools are semi-structured questionnaire (informed consent, demographic details, goniometric measurements), Visual analogue scale (VAS), shoulder pain and disability index (SPADI) and universal goniometer.
Read the detailed description
One of the numerous disorders that causes pain and increase resistance to the active and passive movements of shoulder is the adhesive capsulitis. The pathology of the shoulder can be the extrinsic or intrinsic that induces pain and stiffness that is why the treatment should be according to the actual cause of pathology. Another term which is used for these pathology is 'Frozen Shoulder' which is used by the Codman for the first time in history. Adhesive capsulitis does not represent a single pathology rather it is applicable to most of the conditions that causes myospasm most specifically adhesion that forms in the bursa or joint capsule and rotators of the shoulder. Most specifically the term adhesive capsulitis is actually a pathology that includes the capsule's inflammation which results in thickness and fibrosis and consequently adherence to the shoulder as well as the neck of humerus.
About 2%-5% of the global population is affected by the adhesive Capsulitis that's why it is considered as a common condition. Frozen shoulder the alternative term for adhesive capsulitis affect the 2% of the total world population because of the absent of most accurate criteria for diagnosis and sometime due to the over diagnosis. It is uncommon in people under the age of 40, peak prevalence is in people elder than 40 and younger than 60 and is uncommon in people above 70years except for secondary cause and in the manual workers as according to a cumulative incidence of 2.4 persons per 1000 in a year. Economically the impact of adhesive Capsulitis is underscored i-e 8.2% for men and 10.1% for women for adults in working age. It is more prevalent in women as compared to the men. It cannot develop in the same shoulder after the first time but in 20% of people it is seen to develop in the opposite Shoulder.14% of patients have seen to develop in both shoulders at one time, and 80% are those who develop this condition on opposite side within the next five years.
Frozen shoulder is mostly common in patients suffering from diabetes mellitus. 71.5% of the people are estimated to have the diabetes and frozen shoulder at the same time half of them are previously diagnosed with type I or type II diabetes mellitus and remaining have high glucose tolerance test or increased fasting glucose level.The suspected risk of having frozen shoulder have increased a 10% to 20% in people who are diabetic, having 4% point prevalence, and 2-4 times on greater risk as compared to normal population.
- Conditions
- Adhesive Capsulitis
- Being tested
- Mulligan's Mobilization with movement, Spencer's muscle energy technique, Conventional Therapy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan's Mobilization with movementOther
The Mulligan's technique will be performed as described by Brian Mulligan. 3 sets of 10 repetitions with 1 minute rest between sets.
Spencer's muscle energy techniqueOther
Muscle energy technique that is composed of 7 stages repeated on after the other will be performed. Each movement will be repeated 10 times with 1 minute rest between each set.
Conventional TherapyOther
Electrotherapy-Ultrasound (5-10 mins), Exercise therapy program (isometric, capsular stretching, pectoral stretch and scapular stabilization exercises)
| Study group | Role | What they receive |
|---|---|---|
| Group A-Combined Group | Active comparator | Participants in this group will receive both Mulligan's mobilization with movement and Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks. Receives: Other: Mulligan's Mobilization with movement; Other: Spencer's muscle energy technique; Other: Conventional Therapy |
| Group B-Mulligan Group | Active comparator | Participants in this group will receive Mulligan's mobilization with movement along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks. Receives: Other: Mulligan's Mobilization with movement |
| Group C-Spencer Group | Active comparator | Participants in this group will receive Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks. Receives: Other: Spencer's muscle energy technique |
| Group D-Conventional Group | Active comparator | Participants in this group will receive conventional therapy alone in hospital with home exercise plan. 3 sessions per week will be given for 4 weeks. Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for measurement of pain intensity. The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. It will be used at baseline, after first session and then every week up to 6th week.
Measured: 6th week.
Shoulder Pain and Disability Index
The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with Activity of daily Livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.
It will be used at baseline, every week up to 4th week and then after 2 week follow up on 6th week
Measured: 6th week
Range of Motion
Ranges of motions of all shoulder movements will be measured. These include Flexion, Abduction, Eternal and Internal Rotation. It will be measured at baseline, after first session, every week up to 4th week and then after 2 week follow up on 6th week.
Measured: 6th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start15 Apr 2022
- Primary completion31 Jul 2022
- Study completion30 Aug 2022
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
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450068
- Sponsor's protocol ID
- REC/1012 Bushra
- Status last verified
- Sep 2022
- First submitted
- 9 Apr 2022
- Last updated
- 7 Sep 2022
- 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combining Mobilization With Movement and Spencer's Technique in Diabetic Adhesive Capsulitis Patients
- ClinicalTrials.gov ID
- NCT05450068
- Acronym / sponsor ID
- REC/1012 Bushra
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 8 Jul 2022 (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.
This study will be a randomized control trial conducted on 44 patients diagnosed as adhesive capsulitis in headquarter hospital Gujar khan. Subjects will be divided equally into 4 groups (n=11 in each group) that are Group A, B, C and D by sealed envelope method. Pre-intervention assessment will be done by using data collection tools and then intervention will be applied. Group A will receive mobilization with movement (MWM) technique along with Spencer's muscle energy technique (MET) with conventional therapy. Group B will receive MWM along with conventional therapy. Group C will receive Spencer's MET along with conventional therapy. Group D will receive conventional therapy alone. All subjects will be given a home exercise plan. Assessment will be done after 1st session, 1st week, 2nd week, 3rd week and finally after 2 weeks on follow up using data collection tool. Data collection tools are semi-structured questionnaire (informed consent, demographic details, goniometric measurements), Visual analogue scale (VAS), shoulder pain and disability index (SPADI) and universal goniometer.
Detailed description
One of the numerous disorders that causes pain and increase resistance to the active and passive movements of shoulder is the adhesive capsulitis. The pathology of the shoulder can be the extrinsic or intrinsic that induces pain and stiffness that is why the treatment should be according to the actual cause of pathology. Another term which is used for these pathology is 'Frozen Shoulder' which is used by the Codman for the first time in history. Adhesive capsulitis does not represent a single pathology rather it is applicable to most of the conditions that causes myospasm most specifically adhesion that forms in the bursa or joint capsule and rotators of the shoulder. Most specifically the term adhesive capsulitis is actually a pathology that includes the capsule's inflammation which results in thickness and fibrosis and consequently adherence to the shoulder as well as the neck of humerus.
About 2%-5% of the global population is affected by the adhesive Capsulitis that's why it is considered as a common condition. Frozen shoulder the alternative term for adhesive capsulitis affect the 2% of the total world population because of the absent of most accurate criteria for diagnosis and sometime due to the over diagnosis. It is uncommon in people under the age of 40, peak prevalence is in people elder than 40 and younger than 60 and is uncommon in people above 70years except for secondary cause and in the manual workers as according to a cumulative incidence of 2.4 persons per 1000 in a year. Economically the impact of adhesive Capsulitis is underscored i-e 8.2% for men and 10.1% for women for adults in working age. It is more prevalent in women as compared to the men. It cannot develop in the same shoulder after the first time but in 20% of people it is seen to develop in the opposite Shoulder.14% of patients have seen to develop in both shoulders at one time, and 80% are those who develop this condition on opposite side within the next five years.
Frozen shoulder is mostly common in patients suffering from diabetes mellitus. 71.5% of the people are estimated to have the diabetes and frozen shoulder at the same time half of them are previously diagnosed with type I or type II diabetes mellitus and remaining have high glucose tolerance test or increased fasting glucose level.The suspected risk of having frozen shoulder have increased a 10% to 20% in people who are diabetic, having 4% point prevalence, and 2-4 times on greater risk as compared to normal population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A-Combined Group | Active comparator | Other: Mulligan's Mobilization with movement, Other: Spencer's muscle energy technique, Other: Conventional TherapyParticipants in this group will receive both Mulligan's mobilization with movement and Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks. |
| Group B-Mulligan Group | Active comparator | Other: Mulligan's Mobilization with movementParticipants in this group will receive Mulligan's mobilization with movement along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks. |
| Group C-Spencer Group | Active comparator | Other: Spencer's muscle energy techniqueParticipants in this group will receive Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks. |
| Group D-Conventional Group | Active comparator | Other: Conventional TherapyParticipants in this group will receive conventional therapy alone in hospital with home exercise plan. 3 sessions per week will be given for 4 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both male and female
- Age bracket is 30-70 years
- Pain in the shoulder for at least three months
- All active and passive shoulder movements restricted, with a reduction in external rotation of at least 50%.
Key exclusion criteria (13 listed)
- Patients with
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 |
|---|---|---|
| Mulligan's Mobilization with movementThe Mulligan's technique will be performed as described by Brian Mulligan. 3 sets of 10 repetitions with 1 minute rest between sets. | Other | Group A-Combined Group, Group B-Mulligan Group |
| Spencer's muscle energy techniqueMuscle energy technique that is composed of 7 stages repeated on after the other will be performed. Each movement will be repeated 10 times with 1 minute rest between each set. | Other | Group A-Combined Group, Group C-Spencer Group |
| Conventional TherapyElectrotherapy-Ultrasound (5-10 mins), Exercise therapy program (isometric, capsular stretching, pectoral stretch and scapular stabilization exercises) | Other | Group A-Combined Group, Group D-Conventional Group |
Primary outcome
Visual Analogue Scale
Time frame: 6th week.
A Visual Analogue Scale (VAS) is one of the pain rating scales used for measurement of pain intensity. The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. It will be used at baseline, after first session and then every week up to 6th week.
Shoulder Pain and Disability Index
Time frame: 6th week
The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with Activity of daily Livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. It will be used at baseline, every week up to 4th week and then after 2 week follow up on 6th week
Range of Motion
Time frame: 6th week.
Ranges of motions of all shoulder movements will be measured. These include Flexion, Abduction, Eternal and Internal Rotation. It will be measured at baseline, after first session, every week up to 4th week and then after 2 week follow up on 6th week.
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 7 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Adhesive Capsulitis
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Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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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
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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.
Maria Khalid, MSOMPT 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 Mulligan's Mobilization with movement, Spencer's muscle energy technique and Conventional Therapy 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 4 inclusion and 13 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 7 Sep 2022. 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?
Visual Analogue Scale (time frame: 6th week.). The study lists 3 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 7 Sep 2022.