Adhesive Capsulitis of ShoulderNCT05189626
Effectiveness of Kaltenborn Mobilizations Versus Muscle Energy Technique in Adhesive Capsulitis.
A study testing Muscle energy technique and Kaltonborn mobilizations in people with Adhesive Capsulitis of Shoulder, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
Trial summary
Total of 30 patients are selected according to inclusion criteria by convenient sampling and randomly allocated by sealed envelop method into two groups. Group 1 is treated with Muscle energy technique(Post isometric relaxation) and Group 2 is treated with Grade II,III Kaltenborn mobilizations and both groups also… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- Muscle energy technique and Kaltonborn mobilizations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Dec 2021to 31 Mar 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 60 years.
- Duration of complaint for more than 3 months.
- Gender: Both Male and Female.
- Patients with idiopathic frozen shoulder
- Patients having restriction in more than 2 ranges
- Patients with diabetes
Who cannot join
- Shoulder dislocation, fracture or labral tear.
- Shoulder girdle motor control deficit associated with neurological disorder.
- Any bony deformities acquired or congenital in glenohumeral joint.
- Patients with language barrier.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Holy family hospital
Rawalpindi, Punjab Province, 4400
Nida khan, DPT, 03310404000, knida816@gmail.com
Aqsa Anwar, DPT, 03215172551, aqsaanwar.pt@gmail.com
About this study
Total of 30 patients are selected according to inclusion criteria by convenient sampling and randomly allocated by sealed envelop method into two groups. Group 1 is treated with Muscle energy technique(Post isometric relaxation) and Group 2 is treated with Grade II,III Kaltenborn mobilizations and both groups also receives conventional therapy in form of Codman exercise and Wall ladder exercises.Data will be collected at baseline then after 2 weeks and after 4 weeks of intervention.
Read the detailed description
The purpose of study is to determine effectiveness of muscle energy techniques(Post Isometric relaxation) and Kaltenborn mobilizations and to compare the effectiveness of both techniques on pain and functional disability in patients with Adhesive capsulitis.Several studies about the effects of Maitland mobilizations and Muscle energy technique have been conducted. Evidence regarding the comparison of Kaltenborn mobilizatuons and post isometric relaxation is sparse. There has been no work regarding effectiveness of these two techniques in improving pain and functional disability in patients of Adhesive capsulitis.
Kaltonborn Mobilizations involves the application of a passive sustained stretch technique to enhance joint mobility without articular surface suppression. The forces applied to increase joint mobility are graded from I-III. Grade I applies a distraction of minor intensity that hardly causes stress within the joint capsule; it is often used to decrease pain. Grade II refers to a force that stretches the periarticular tissue; such stimulus is colloquially referred to as "taking up the slack." Finally, Grade III force causes enough distraction or gliding so that joint capsule can sufficiently stretch; it is often used for enhancing ROM.
MET is unique in its application as the client provides the initial effort while the practitioner facilitates the process. One of the main uses of this method is to normalize joint range, rather than increase flexibility, and techniques can be used on any joints with restricted Range of Motion (ROM) identified during the passive assessment. The main effects of MET can be explained by two distinct physiological processes: Post Isometric Relaxation (PIR) and Reciprocal Inhibition (RI). Post isometric contraction decrease muscle tone in single group of muscle after brief period of submaximal isometric contraction of same muscle.
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- Muscle energy technique, Kaltonborn mobilizations
- Keywords
- Adhesive Capsulitis,Mobilizations, muscle energy technique
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle energy techniqueOther
Post Isometric relaxation(muscle energy technique) 3 days/ week for 4 weeks
Kaltonborn mobilizationsOther
Kaltonborn mobilizations grade II and III will be performed on Glenohumeral joints 3 days/ week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Muscle energy technique Receives: Other: Muscle energy technique |
| Group B | Experimental | Kaltonborn mobilizations Receives: Other: Kaltonborn mobilizations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain and disability index
Shoulder pain and disability index is used to measure pain and functional disability level. Total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction
Measured: 4 weeks
Universal goniometer
universal goniometer is used to measure shoulder range of motion.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start6 Dec 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- 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
- Model description
- There are two groups Group 1 and 2.Group 1 is treated with Muscle energy techniques and Group 2 is treated with kaltenborn mobilizations for 30 minutes per session,3 days per week for 4 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Education Research Foundation (HERF)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aqsa Anwar, DPT, Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189626
- Sponsor's protocol ID
- 142/IREF/RMU/2021
- Status last verified
- Jan 2022
- First submitted
- 11 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kaltenborn Mobilizations Versus Muscle Energy Technique in Adhesive Capsulitis.
- ClinicalTrials.gov ID
- NCT05189626
- Acronym / sponsor ID
- 142/IREF/RMU/2021
- Conditions
- Adhesive Capsulitis of Shoulder
- Keywords
- Adhesive Capsulitis,Mobilizations, muscle energy technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Health Education Research Foundation (HERF)University, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 12 Jan 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.
Total of 30 patients are selected according to inclusion criteria by convenient sampling and randomly allocated by sealed envelop method into two groups. Group 1 is treated with Muscle energy technique(Post isometric relaxation) and Group 2 is treated with Grade II,III Kaltenborn mobilizations and both groups also receives conventional therapy in form of Codman exercise and Wall ladder exercises.Data will be collected at baseline then after 2 weeks and after 4 weeks of intervention.
Detailed description
The purpose of study is to determine effectiveness of muscle energy techniques(Post Isometric relaxation) and Kaltenborn mobilizations and to compare the effectiveness of both techniques on pain and functional disability in patients with Adhesive capsulitis.Several studies about the effects of Maitland mobilizations and Muscle energy technique have been conducted. Evidence regarding the comparison of Kaltenborn mobilizatuons and post isometric relaxation is sparse. There has been no work regarding effectiveness of these two techniques in improving pain and functional disability in patients of Adhesive capsulitis.
Kaltonborn Mobilizations involves the application of a passive sustained stretch technique to enhance joint mobility without articular surface suppression. The forces applied to increase joint mobility are graded from I-III. Grade I applies a distraction of minor intensity that hardly causes stress within the joint capsule; it is often used to decrease pain. Grade II refers to a force that stretches the periarticular tissue; such stimulus is colloquially referred to as "taking up the slack." Finally, Grade III force causes enough distraction or gliding so that joint capsule can sufficiently stretch; it is often used for enhancing ROM.
MET is unique in its application as the client provides the initial effort while the practitioner facilitates the process. One of the main uses of this method is to normalize joint range, rather than increase flexibility, and techniques can be used on any joints with restricted Range of Motion (ROM) identified during the passive assessment. The main effects of MET can be explained by two distinct physiological processes: Post Isometric Relaxation (PIR) and Reciprocal Inhibition (RI). Post isometric contraction decrease muscle tone in single group of muscle after brief period of submaximal isometric contraction of same muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- There are two groups Group 1 and 2.Group 1 is treated with Muscle energy techniques and Group 2 is treated with kaltenborn mobilizations for 30 minutes per session,3 days per week for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Muscle energy techniqueMuscle energy technique |
| Group B | Experimental | Other: Kaltonborn mobilizationsKaltonborn mobilizations |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 20 and 60 years.
- Duration of complaint for more than 3 months.
- Gender: Both Male and Female.
- Patients with idiopathic frozen shoulder
- Patients having restriction in more than 2 ranges
Key exclusion criteria (4 listed)
- Shoulder dislocation, fracture or labral tear.
- Shoulder girdle motor control deficit associated with neurological disorder.
- Any bony deformities acquired or congenital in glenohumeral joint.
- Patients with language barrier.
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 |
|---|---|---|
| Muscle energy techniquePost Isometric relaxation(muscle energy technique) 3 days/ week for 4 weeks | Other | Group A |
| Kaltonborn mobilizationsKaltonborn mobilizations grade II and III will be performed on Glenohumeral joints 3 days/ week for 4 weeks. | Other | Group B |
Primary outcome
Shoulder pain and disability index
Time frame: 4 weeks
Shoulder pain and disability index is used to measure pain and functional disability level. Total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction
Universal goniometer
Time frame: 4 weeks
universal goniometer is used to measure shoulder range of motion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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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.
Aqsa Anwar, DPT principal investigator
Rawalpindi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle energy technique and Kaltonborn mobilizations in people with Adhesive Capsulitis of Shoulder, run by Health Education Research Foundation (HERF) 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waqar Ahmed Awan, PhD (+923335348846, president@herf.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain and disability index (time frame: 4 weeks). 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 12 Jan 2022.