Adhesive CapsulitisNCT04157387
Cyriax Inferior Capsule Stretching in Idiopathic Adhesive Capsulitis
A study testing Cyriax inferior capsular stretching + Manual Therapy and Manual therapy in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The objective of study is to find out the effectiveness of cyriax capsular stretching in idiopathic adhesive capsulitis and to find out the combined effect of capsular stretching's, mobilization and conservative treatment on pain and Range of Motion (ROM) in idiopathic adhesive capsulitis. 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?
- Cyriax inferior capsular stretching + Manual Therapy and Manual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2018to 30 Jun 2018
- 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
- Idiopathic Adhesive capsulitis phase 1 and phase 2
- Follow capsular pattern ( ER > Abduction> IR)
Who cannot join
- Adhesive capsulitis phase 3
- Any intrinsic etiology i.e. rheumatoid arthritis,
- infection,
- gout,
- haemarthrosis or
- tumor or Arthritis in stage III or in stage II with a spastic end-feel
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International university
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effect of Cyriax Inferior Capsule Stretching in Idiopathic Adhesive Capsulitis
The objective of study is to find out the effectiveness of cyriax capsular stretching in idiopathic adhesive capsulitis and to find out the combined effect of capsular stretching's, mobilization and conservative treatment on pain and Range of Motion (ROM) in idiopathic adhesive capsulitis.
Read the detailed description
This Randomized study was carried out at Pakistan Railway Hospital Rawalpindi. A total of 28 patients were screened out as per inclusion criteria and randomly placed into two groups A and B through lottery method. The Visual Analogue scale, Shoulder Pain and Disability Index, and Range of Motion of shoulder joint were used as outcome measures. All the patients were assessed at baseline before intervention and at the completion of 3weeks of treatment.
- Conditions
- Adhesive Capsulitis
- Being tested
- Cyriax inferior capsular stretching + Manual Therapy, Manual therapy
- Keywords
- Adhesive Capsulitis, Cyriax Manual Therapy, Stretching
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyriax inferior capsular stretching + Manual TherapyOther
Electro-therapy 10mins Manual therapy : Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Active ROM exercises : 10 reps x 3 sets Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each) Cyriax inferior capsular stretching
Manual therapyOther
Before starting capsule stretching technique, Analgesic short-wave diathermy may be given for 10 minutes.
Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each)
| Study group | Role | What they receive |
|---|---|---|
| Cyriax inferior capsular stretching + Manual Therapy | Experimental | Cyriax inferior capsular stretching
+ Electrotherapy Manual therapy : Kaltenborn grade 1 and 2 Mobilization
Active ROM exercises :
Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction Receives: Other: Cyriax inferior capsular stretching + Manual Therapy |
| Manual Therapy | Active comparator | Analgesic short-wave diathermy Manual Therapy: Kalternbon grade 1 and 2 Mobilization :, Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction. Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
Changes from the baseline, Measure the available range of motion or the position of the shoulder joint - typically this is a measure of passive motion like External Rotation, External Rotation and Internal Rotation.
Measured: 3rd week
Visual Analogue Scale (VAS)
Changes from the baseline, Normative values are not presented so by using a ruler , the score is calculated by measure the distance on 10cm line between the "no pain" point and the patient's mark, provide a range of score from 0-100. A higher score indicates greater pain intensity.
Measured: 3rd Week
Shoulder pain and disability index (SPADI)
Changes from the Baseline, SPADI is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease. It consists of two dimensions, one for pain and second for functional activities.
The pain element consists of five questions regarding severity of pain and to measure the degree of severity that an individual faced during various activities of daily life that involve upper extremity use. There are eight questions.
Each subscale is summed up and a total SPADI score is expressed as a percentage.Total pain score : --/50 ×100 = %, Total disability score: --/80 × 100 = %, Total SPADI score: --/130 × 100 = %.
A score of 0 indicates best 100 indicates worst. A higher score shows more disability.
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul Ghafoor Sajjad, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157387
- Sponsor's protocol ID
- RiphahIU Ramsha Tariq
- Status last verified
- Jan 2020
- First submitted
- 6 Nov 2019
- Last updated
- 10 Jan 2020
- 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 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cyriax Inferior Capsule Stretching in Idiopathic Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT04157387
- Acronym / sponsor ID
- RiphahIU Ramsha Tariq
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive Capsulitis, Cyriax Manual Therapy, Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 8 Nov 2019 (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 objective of study is to find out the effectiveness of cyriax capsular stretching in idiopathic adhesive capsulitis and to find out the combined effect of capsular stretching's, mobilization and conservative treatment on pain and Range of Motion (ROM) in idiopathic adhesive capsulitis.
Detailed description
This Randomized study was carried out at Pakistan Railway Hospital Rawalpindi. A total of 28 patients were screened out as per inclusion criteria and randomly placed into two groups A and B through lottery method. The Visual Analogue scale, Shoulder Pain and Disability Index, and Range of Motion of shoulder joint were used as outcome measures. All the patients were assessed at baseline before intervention and at the completion of 3weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyriax inferior capsular stretching + Manual Therapy | Experimental | Other: Cyriax inferior capsular stretching + Manual TherapyCyriax inferior capsular stretching + Electrotherapy Manual therapy : Kaltenborn grade 1 and 2 Mobilization Active ROM exercises : Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction |
| Manual Therapy | Active comparator | Other: Manual therapyAnalgesic short-wave diathermy Manual Therapy: Kalternbon grade 1 and 2 Mobilization :, Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic Adhesive capsulitis phase 1 and phase 2
- Follow capsular pattern ( ER > Abduction> IR)
Key exclusion criteria (6 listed)
- Adhesive capsulitis phase 3
- Any intrinsic etiology i.e. rheumatoid arthritis,
- infection,
- gout,
- haemarthrosis or
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 |
|---|---|---|
| Cyriax inferior capsular stretching + Manual TherapyElectro-therapy 10mins Manual therapy : Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Active ROM exercises : 10 reps x 3 sets Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each) Cyriax inferior capsular stretching | Other | Cyriax inferior capsular stretching + Manual Therapy |
| Manual therapyBefore starting capsule stretching technique, Analgesic short-wave diathermy may be given for 10 minutes. Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each) | Other | Manual Therapy |
Primary outcome
Goniometer
Time frame: 3rd week
Changes from the baseline, Measure the available range of motion or the position of the shoulder joint - typically this is a measure of passive motion like External Rotation, External Rotation and Internal Rotation.
Visual Analogue Scale (VAS)
Time frame: 3rd Week
Changes from the baseline, Normative values are not presented so by using a ruler , the score is calculated by measure the distance on 10cm line between the "no pain" point and the patient's mark, provide a range of score from 0-100. A higher score indicates greater pain intensity.
Shoulder pain and disability index (SPADI)
Time frame: 3rd week
Changes from the Baseline, SPADI is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease. It consists of two dimensions, one for pain and second for functional activities. The pain element consists of five questions regarding severity of pain and to measure the degree of severity that an individual faced during various activities of daily life that involve upper extremity use. There are eight questions. Each subscale is summed up and a total SPADI score is expressed as a percentage.Total pain score : --/50 ×100 = %, Total disability score: --/80 × 100 = %, Total SPADI score: --/130 × 100 = %. A score of 0 indicates best 100 indicates worst. A higher score shows more disability.
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 10 Jan 2020.
- 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
Frozen Shoulder, Adhesive Capsulitis
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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.
Abdul Ghafoor Sajjad, 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 Cyriax inferior capsular stretching + Manual Therapy and Manual 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 2 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 10 Jan 2020. 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?
Goniometer (time frame: 3rd 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 10 Jan 2020.