Adhesive Capsulitis of ShoulderNCT05274698
Efficacy Of Muscle Energy Technique On Shoulder Adhesive Capsulitis Post Mastectomy
A study testing muscle energy technique and conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks. in people with Adhesive Capsulitis of Shoulder, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the effect of muscle energy technique on adhesive capsulitis post mastectomy. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- muscle energy technique and conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Female patients with age range between 40-60 years.
- Shoulder ROM restriction.
- Shoulder pain more than 3 months.
- Patients with adhesive capsulitis abduction test and external rotation test positive.
- Patients referral adhesive capsulitis with MRI
Who cannot join
- • Disease such as rheumatoid arthritis
- Diabetes mellitus.
- History of trauma or accidental injuries.
- Neurological involvement (stroke, Parkinsonism, radiating pain to arm).
- History of surgery on particular shoulder
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Dokki, Giza Governorate, 12611
faculty of physical therapy, 0237617691, Info@pt.cu.edu.eg
l
About this study
The purpose of the study is to evaluate the effect of muscle energy technique on adhesive capsulitis post mastectomy.
Read the detailed description
- Subjects: Sixty patients who have adhesive capsulitis post- mastectomy will participate in this study .Their ages will range from 40 to 60 years. The participants will be selected from National Cancer Institute, Cairo University and randomly distributed into two equal groups. 1.1 Design of the study: In this study the patients will be randomly assigned into two equal groups (30 patients for each group): 1.1(a) Group A (Experimental group): This group includes 30 patients with adhesive capsulitis who will receive muscle energy techniques 1 session per day, 5 days a week for 8 weeks in addition to their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises). 1.1(b) Group B (Control group): This group includes 30 patients with adhesive capsulitis who will receive their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.
- Equipment:
2.1- Measurement equipment: 2.1.a-Visual analogue scale (VAS): The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
2.1.b-Goniometer :
One of the most common assessment methods is measuring range of motion (ROM) of the joint using a goniometer. This method has been used for almost 90 years. Baseline limitation on ROM of a patient can be obtained before treatment, and changes induced in this motion after therapeutic interventions is easily determined. Reliability studies on ROM measurement of the joint using goniometer have been studied in depth, and have shown high reliability 2.1.c-Shoulder Pain and Disability Index (SPADI):
Is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease .The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability .
- 2-Therapeutic equipment and tools: 3-Procedures of the study: 3.1-Measurement procedures: 3.1.a-A Visual Analogue Scale (VAS):
VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, as illustrated in Fig. (1).The patient will mark on the line the point that they feel represents their perception of their current state. The VAS score will be determined by measuring in millimetres from the left hand end of the line to the point that the patient mark .
3.1.b- Goniometer: ( From supine lying position ,the measurements will be taken for shoulder flexion, abduction, and external rotation).
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- muscle energy technique, conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.
- 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 techniqueBehavioural
It is a manual treatment in which a patient produces a contraction in a precisely controlled position and direction against a counterforce applied by a manual therapist .Muscle energy techniques (MET) were originally developed to treat soft tissue, mobilize joints, stretch tight muscles and fascia, reduce pain and to improve circulation and lymphatic drainage.
conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.Behavioural
Joint mobilization, specifically glenohumeral joint distraction, glenohumeral joint caudal glide, glenohumeral joint posterior glide, and glenohumeral joint anterior glide, will be applied with patients.
Posterior capsule stretching will be applied with patients in side lying position. The scapula will be stabilized at the lateral side with the arm at 90° flexion. Stretching will be applied from the elbow with a downward force. The stretch will be repeated 10 times for 20 s each. A 30-s break will be given between each stretching .
Range of motion exercises:
Codman/ pendulum exercise ,Wall climbing exercise and Shoulder wheel exercise Circumduction of the shoulder joint clockwise and anticlockwise using shoulder wheel
| Study group | Role | What they receive |
|---|---|---|
| Group A (Experimental group): | Experimental | This group includes 30 patients with adhesive capsulitis who will receive muscle energy techniques 1 session per day, 5 days a week for 8 weeks in addition to their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises). Receives: Behavioral: muscle energy technique; Behavioral: conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks. |
| Group B (Control group): | Other | This group includes 30 patients with adhesive capsulitis who will receive their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks. Receives: Behavioral: conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: 2 month
Secondary outcomes (1)
Goniometer
( From supine lying position ,the measurements will be taken for shoulder flexion, abduction, and external rotation).
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Feb 2022
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (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.
- More trials run by Cairo 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Gameil Fakhry Serg, Cairo University
- Investigators
- faculty of physical therapy, Study director, teaching assistant of physical therapy cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274698
- Sponsor's protocol ID
- P.T.REC/012/003434
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Muscle Energy Technique On Shoulder Adhesive Capsulitis Post Mastectomy
- ClinicalTrials.gov ID
- NCT05274698
- Acronym / sponsor ID
- P.T.REC/012/003434
- Conditions
- Adhesive Capsulitis of Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 10 Mar 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.
The purpose of the study is to evaluate the effect of muscle energy technique on adhesive capsulitis post mastectomy.
Detailed description
- Subjects: Sixty patients who have adhesive capsulitis post- mastectomy will participate in this study .Their ages will range from 40 to 60 years. The participants will be selected from National Cancer Institute, Cairo University and randomly distributed into two equal groups. 1.1 Design of the study: In this study the patients will be randomly assigned into two equal groups (30 patients for each group): 1.1(a) Group A (Experimental group): This group includes 30 patients with adhesive capsulitis who will receive muscle energy techniques 1 session per day, 5 days a week for 8 weeks in addition to their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises). 1.1(b) Group B (Control group): This group includes 30 patients with adhesive capsulitis who will receive their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.
- Equipment:
2.1- Measurement equipment: 2.1.a-Visual analogue scale (VAS): The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
2.1.b-Goniometer :
One of the most common assessment methods is measuring range of motion (ROM) of the joint using a goniometer. This method has been used for almost 90 years. Baseline limitation on ROM of a patient can be obtained before treatment, and changes induced in this motion after therapeutic interventions is easily determined. Reliability studies on ROM measurement of the joint using goniometer have been studied in depth, and have shown high reliability 2.1.c-Shoulder Pain and Disability Index (SPADI):
Is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease .The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability .
- 2-Therapeutic equipment and tools: 3-Procedures of the study: 3.1-Measurement procedures: 3.1.a-A Visual Analogue Scale (VAS):
VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, as illustrated in Fig. (1).The patient will mark on the line the point that they feel represents their perception of their current state. The VAS score will be determined by measuring in millimetres from the left hand end of the line to the point that the patient mark .
3.1.b- Goniometer: ( From supine lying position ,the measurements will be taken for shoulder flexion, abduction, and external rotation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Experimental group): | Experimental | Behavioral: muscle energy technique, Behavioral: conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.This group includes 30 patients with adhesive capsulitis who will receive muscle energy techniques 1 session per day, 5 days a week for 8 weeks in addition to their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises). |
| Group B (Control group): | Other | Behavioral: conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.This group includes 30 patients with adhesive capsulitis who will receive their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Female patients with age range between 40-60 years.
Key exclusion criteria (5 listed)
- • Disease such as rheumatoid arthritis
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 techniqueIt is a manual treatment in which a patient produces a contraction in a precisely controlled position and direction against a counterforce applied by a manual therapist .Muscle energy techniques (MET) were originally developed to treat soft tissue, mobilize joints, stretch tight muscles and fascia, reduce pain and to improve circulation and lymphatic drainage. | Behavioural | Group A (Experimental group): |
| conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.Joint mobilization, specifically glenohumeral joint distraction, glenohumeral joint caudal glide, glenohumeral joint posterior glide, and glenohumeral joint anterior glide, will be applied with patients. Posterior capsule stretching will be applied with patients in side lying position. The scapula will be stabilized at the lateral side with the arm at 90° flexion. Stretching will be applied from the elbow with a downward force. The stretch will be repeated 10 times for 20 s each. A 30-s break will be given between each stretching . Range of motion exercises: Codman/ pendulum exercise ,Wall climbing exercise and Shoulder wheel exercise Circumduction of the shoulder joint clockwise and anticlockwise using shoulder wheel | Behavioural | Group A (Experimental group):, Group B (Control group): |
Primary outcome
Visual analogue scale (VAS)
Time frame: 2 month
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
1 secondary outcome
Goniometer
Time frame: 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Adhesive Capsulitis of Shoulder
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
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.
faculty of physical therapy study director
teaching assistant of physical therapy cairo 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 muscle energy technique and conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks. in people with Adhesive Capsulitis of Shoulder, run by Cairo University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 31 Mar 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 Egypt. 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 samah fakhry, master (01129688461, samah_gameil@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 2 month). 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 31 Mar 2022.