Adhesive CapsulitisNCT05655611
Muscle Energy Technique With Or Without First Rib Mobilization In Adhesive Capsulitis
A study testing first rib mobilization and muscle energy technique 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. Study will be conducted in 40 patients in the age range 40-70 years, which will be selected by using non proability convenient sampling technique. Subjects will be divided in 2 groups. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- first rib mobilization and muscle energy technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2022to 7 Mar 2023
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-70 years
- Gender (both male and female)
- Subjects with adhesive capsulitis stage (II and III)
Who cannot join
- Previous surgery on affected shoulder
- Recent trauma to shoulder
- fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Muscle Energy Technique With Or Without First Rib Mobilization On Range Of Motion And Pain In Adhesive Capsulitis
This study will be a randomized control trial. Study will be conducted in 40 patients in the age range 40-70 years, which will be selected by using non proability convenient sampling technique. Subjects will be divided in 2 groups. Group A will receive first rib mobilization along with METS and conventional treatment, group B will receive METS and conventional physical therapy treatment only. Treatment will be given thrice per week for 3 weeks. Data will be collected pre and post treatment, for data collection numeric pain rating scale, shoulder pain and disability index (SPADI) will be used. Joint range of motion will be measured using goniometer. After collection data from defined study setting, data will be entered and analyzed at Riphah International University, Lahore.
Read the detailed description
Adhesive capsulitis, also known as "frozen shoulder," is a common condition of the shoulder defined as a pathologic process in which contracture of the gleno-humeral capsule is a hallmark. Clinically, it presents as pain, stiffness, and dysfunction of the affected shoulder. Adhesive capsulitis is thought to afflict between 2 and 5% of the general population, with women affected more frequently than men. Individuals of middle age are most often affected, typically during the 5th to 7th decades of life.
Muscle energy techniques is a manual therapy that uses the gentle muscle contractions to relax and lengthen muscles and normalize joint motion. It is a class of soft tissue osteopathic manipulation consisting of isometric contraction designed to improve musculoskeletal function and reduce pain. The application of MET relaxes and improves biomechanics and result in improving functional ability.
Although conventional physical therapy treatment are used to treat frozen shoulder and effectiveness of muscle energy technique is proven, but the effect of first rib mobilization and MET has not been studied.
- Conditions
- Adhesive Capsulitis
- Being tested
- first rib mobilization, muscle energy technique
- Keywords
- muscle energy technique, first rib mobilization
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first rib mobilizationOther
Also called first rib maitland mobilization
To perform the first rib mobilization, the patient remained lying supine with the head in the examiner's right hand. Examiner then palpated the left first rib and passively side-bended the patient's head to the left to relieve any muscular tension on the first rib. Patient was then asked to take a deep breath in and out. During exhalation, the examiner applied pressure to depress the first rib, holding it in place at the end of the exhalation. Then, holding the first rib in place, the patient was asked to inhale and exhale deeply again. The examiner continued applying pressure to hold the first rib in a position of relative depression during inhalation, and further depressed the first rib as able during exhalation. This process was repeated three times in two sets, for a total of six first rib depression mobilizations.
muscle energy techniqueOther
Also called muscle energy technique for shoulder
Muscle energy technique for glenohumeral joint restricted abduction-The therapist stood in front of the patient, then placed one hand over the top of the subject's involved shoulder. The therapist cups the glenohumeral joint to palpate for motion and the subjects are directed to press the elbow towards their body. Muscle energy technique was applied for five repetitions per set, five sets per session, one session per day, three days a week for three weeks with each repetition maintained for the duration of 7-1 seconds.
| Study group | Role | What they receive |
|---|---|---|
| first rib mobilization | Experimental | To perform the first rib mobilization, the patient remained lying supine with the head in the examiner's right hand. Examiner then palpated the left first rib and passively side-bended the patient's head to the left to relieve any muscular tension on the first rib. Patient was then asked to take a deep breath in and out. During exhalation, the examiner applied pressure to depress the first rib, holding it in place at the end of the exhalation. Then, holding the first rib in place, the patient was asked to inhale and exhale deeply again. The examiner continued applying pressure to hold the first rib in a position of relative depression during inhalation, and further depressed the first rib as able during exhalation. This process was repeated three times in two sets, for a total of six first rib depression mobilizations Receives: Other: first rib mobilization |
| muscle energy technique | Active comparator | All the patients will receive conventional physical therapy treatment and muscle energy techniques for shoulder flexion, abduction, internal and external rotation. Muscle energy technique was applied for five repetitions per set, five sets per session, one session per day, three days a week for three weeks with each repetition maintained for the duration of 7-10 seconds Receives: Other: muscle energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale for pain
Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable
Measured: 3 weeks
shoulder pain and disability index for shoulder pain
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
Measured: 3 weeks
Secondary outcomes (1)
goniometer for measuring shoulder ranges
it is used to measure shoulder ranges such as flexion, abduction , internal and external rotation
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start10 Oct 2022
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, MS, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655611
- Sponsor's protocol ID
- REC/RCR&AH/21/0130/SIDRA
- Status last verified
- Mar 2023
- First submitted
- 9 Dec 2022
- Last updated
- 16 Mar 2023
- Results posted
- 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Muscle Energy Technique With Or Without First Rib Mobilization On Range Of Motion And Pain In Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05655611
- Acronym / sponsor ID
- REC/RCR&AH/21/0130/SIDRA
- Conditions
- Adhesive Capsulitis
- Keywords
- muscle energy technique, first rib mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 19 Dec 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. Study will be conducted in 40 patients in the age range 40-70 years, which will be selected by using non proability convenient sampling technique. Subjects will be divided in 2 groups. Group A will receive first rib mobilization along with METS and conventional treatment, group B will receive METS and conventional physical therapy treatment only. Treatment will be given thrice per week for 3 weeks. Data will be collected pre and post treatment, for data collection numeric pain rating scale, shoulder pain and disability index (SPADI) will be used. Joint range of motion will be measured using goniometer. After collection data from defined study setting, data will be entered and analyzed at Riphah International University, Lahore.
Detailed description
Adhesive capsulitis, also known as "frozen shoulder," is a common condition of the shoulder defined as a pathologic process in which contracture of the gleno-humeral capsule is a hallmark. Clinically, it presents as pain, stiffness, and dysfunction of the affected shoulder. Adhesive capsulitis is thought to afflict between 2 and 5% of the general population, with women affected more frequently than men. Individuals of middle age are most often affected, typically during the 5th to 7th decades of life.
Muscle energy techniques is a manual therapy that uses the gentle muscle contractions to relax and lengthen muscles and normalize joint motion. It is a class of soft tissue osteopathic manipulation consisting of isometric contraction designed to improve musculoskeletal function and reduce pain. The application of MET relaxes and improves biomechanics and result in improving functional ability.
Although conventional physical therapy treatment are used to treat frozen shoulder and effectiveness of muscle energy technique is proven, but the effect of first rib mobilization and MET has not been studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first rib mobilization | Experimental | Other: first rib mobilizationTo perform the first rib mobilization, the patient remained lying supine with the head in the examiner's right hand. Examiner then palpated the left first rib and passively side-bended the patient's head to the left to relieve any muscular tension on the first rib. Patient was then asked to take a deep breath in and out. During exhalation, the examiner applied pressure to depress the first rib, holding it in place at the end of the exhalation. Then, holding the first rib in place, the patient was asked to inhale and exhale deeply again. The examiner continued applying pressure to hold the first rib in a position of relative depression during inhalation, and further depressed the first rib as able during exhalation. This process was repeated three times in two sets, for a total of six first rib depression mobilizations |
| muscle energy technique | Active comparator | Other: muscle energy techniqueAll the patients will receive conventional physical therapy treatment and muscle energy techniques for shoulder flexion, abduction, internal and external rotation. Muscle energy technique was applied for five repetitions per set, five sets per session, one session per day, three days a week for three weeks with each repetition maintained for the duration of 7-10 seconds |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 40-70 years
- Gender (both male and female)
- Subjects with adhesive capsulitis stage (II and III)
Key exclusion criteria (3 listed)
- Previous surgery on affected shoulder
- Recent trauma to shoulder
- fracture
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 |
|---|---|---|
| first rib mobilizationAlso: first rib maitland mobilizationTo perform the first rib mobilization, the patient remained lying supine with the head in the examiner's right hand. Examiner then palpated the left first rib and passively side-bended the patient's head to the left to relieve any muscular tension on the first rib. Patient was then asked to take a deep breath in and out. During exhalation, the examiner applied pressure to depress the first rib, holding it in place at the end of the exhalation. Then, holding the first rib in place, the patient was asked to inhale and exhale deeply again. The examiner continued applying pressure to hold the first rib in a position of relative depression during inhalation, and further depressed the first rib as able during exhalation. This process was repeated three times in two sets, for a total of six first rib depression mobilizations. | Other | first rib mobilization |
| muscle energy techniqueAlso: muscle energy technique for shoulderMuscle energy technique for glenohumeral joint restricted abduction-The therapist stood in front of the patient, then placed one hand over the top of the subject's involved shoulder. The therapist cups the glenohumeral joint to palpate for motion and the subjects are directed to press the elbow towards their body. Muscle energy technique was applied for five repetitions per set, five sets per session, one session per day, three days a week for three weeks with each repetition maintained for the duration of 7-1 seconds. | Other | muscle energy technique |
Primary outcome
Numeric pain rating scale for pain
Time frame: 3 weeks
Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable
shoulder pain and disability index for shoulder pain
Time frame: 3 weeks
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
1 secondary outcome
goniometer for measuring shoulder ranges
Time frame: 3 weeks
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 16 Mar 2023.
- Individual participant dataSharing planned: No
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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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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.
Muhammad Sanaullah, MS principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing first rib mobilization and muscle energy 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 3 inclusion and 3 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 16 Mar 2023. 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 for pain (time frame: 3 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 16 Mar 2023.