Frozen ShoulderNCT05811533
Comparison of Spencer's Muscle Energy Technique and Post-facilitation Stretch in Patients With Adhesive Capsulitis
A study testing Spencer's MET with conventional therapy and Post-Facilitation Stretch with conventional therapy in people with Frozen Shoulder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Adhesive capsulitis is one of the most common problems of the upper limb. Adhesive capsulitis (AC) and frozen shoulder syndrome (FSS) are two terms that have been used to describe a painful and stiff shoulder. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Spencer's MET with conventional therapy and Post-Facilitation Stretch with conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 10 Jul 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with primary unilateral adhesive capsulitis
- Stage II and III adhesive capsulitis
- Patients with limited active and passive Range of Motion of the affected shoulder (globally loss of at least 50% compared to non-involved shoulder in one or more directions)
- Patients with controlled diabetes
Who cannot join
- Patients with a positive history of trauma, fracture, or surgery of the cervical spine
- Corticosteroid injection in the affected shoulder in the preceding 4 weeks.
- Malignancy/Avascular Necrosis of shoulder
- Post-traumatic shoulder stiffness
- Thoracic outlet syndrome/neurological disorder
- Patients with cervical radiculopathy
Trial locations and contacts
1 site in 1 country.
About this study
Adhesive capsulitis is one of the most common problems of the upper limb. Adhesive capsulitis (AC) and frozen shoulder syndrome (FSS) are two terms that have been used to describe a painful and stiff shoulder.
Conservative treatment includes transcutaneous electrical nerve stimulation (TENS), Ultrasound, LASER, Range of Motion, stretching and strengthening exercises, patient education, and home exercises. Manual therapy includes mobilization, Spencer's Muscle Energy Technique and Mobilization With Movement.
Read the detailed description
The American Academy of Orthopedic Surgeons defines this condition as: "A condition of varying severity characterized by the gradual development of global limitation of active and passive shoulder motion where radiographic findings other than osteopenia are absent." Patients with frozen shoulder typically experience insidious shoulder stiffness, severe pain that usually worsens at night, and near-complete loss of passive and active external rotation of the shoulder.
Although spencer's Muscle Energy Technique is a very effective technique, still it was rarely used. It is a standardized series of steps of shoulder treatments with broad application in diagnosis, treatment, and prognosis developed by Spencer in 1961 and is a well-known osteopathic manipulative technique that focuses on mobilization of the glenohumeral and scapulothoracic joints. It is an articulatory technique in which passive, smooth, rhythmic motion of the shoulder joint is done by the therapist to stretch contracted muscles, ligaments, and capsule. Most of the force is applied at the end range of motion. This technique increases pain-free Range of Motion by stretching the tissues, enhancing lymphatic flow, and stimulating increased joint circulation.
On the other hand, "post-facilitation stretch (PFS)" is a muscle energy technique developed by Dr.Vladimir Janda to lengthen chronically shortened muscles that involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a 20-second static stretch. This technique is more aggressive than Post Isometric Relaxation and based on the concept of autogenic inhibition
- Conditions
- Frozen Shoulder
- Being tested
- Spencer's MET with conventional therapy, Post-Facilitation Stretch with conventional therapy
- Keywords
- spencer Muscle energy technique, post facilitation, pain, range of motion
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spencer's MET with conventional therapyOther
Patients will be asked to lie in a side lying position with the affected shoulder above. The therapist will stabilize the shoulder girdle with the proximal hand and the distal hand provided force into the restrictive barrier of shoulder in 7 different movements. During all the movements, patients will ask to use their muscle energy 20% against the slight resistance offered by the therapist for 3-5 seconds. The patient then asks to relax and exhale after that shoulder joint will move beyond the barrier to achieve the next barrier. After 20 sec of rest, this technique will be repeated 3-5 times
Post-Facilitation Stretch with conventional therapyOther
Muscle Energy Technique [Post Facilitation Stretch)] for the shoulder joint will be applied with 3 repetitions per set, 1 session per day. Patient will be instructed to perform a full strength contraction of the muscle to be stretch for 10 seconds. The muscle is then allow to fully relax, whereupon a rapid stretch of the affected muscle will be performed and will held in position by the physician for 15 sec. Patient will be asked to relax and whole cycle will be repeated
| Study group | Role | What they receive |
|---|---|---|
| Spencer's MET with conventional therapy | Experimental | Patients will be asked to lie in a side lying position with the affected shoulder above. The therapist will stabilize the shoulder girdle with the proximal hand and the distal hand provided force into the restrictive barrier of shoulder in 7 different movements. During all the movements, patients will ask to use their muscle energy 20% against the slight resistance offered by the therapist for 3-5 seconds. The patient then asks to relax and exhale after that shoulder joint will move beyond the barrier to achieve the next barrier. After 20 sec of rest, this technique will be repeated 3-5 times Receives: Other: Spencer's MET with conventional therapy |
| Post-Facilitation Stretch with conventional therapy | Experimental | Muscle Energy Technique [Post Facilitation Stretch)] for the shoulder joint will be applied with 3 repetitions per set, 1 session per day. Patient will be instructed to perform a full strength contraction of the muscle to be stretch for 10 seconds. The muscle is then allow to fully relax, whereupon a rapid stretch of the affected muscle will be performed and will held in position by the physician for 15 sec. Patient will be asked to relax and whole cycle will be repeated. Receives: Other: Post-Facilitation Stretch with conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Numeric Pain Rating Scale)
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable
Measured: four weeks
Goniometer
A goniometer is a device that measures an angle or permits the rotation of an object to a definite position. To measure the range of motion, doctors, osteopaths, physical therapists, or other health professionals most commonly use a goniometer, which is an instrument that measures angle motion at a joint
Measured: four weeks
SPADI (Shoulder Pain and Disability Index)
The shoulder pain and disability index (SPADI) is also a reliable and valid clinimetric (Cronbach-α>0.90), self-administered questionnaire used by orthopedics and physical therapists for proper assessment of shoulder related pain and disabilities in terms of functional outcomes in patients suffering from different types of the shoulder-related pathologies. It consists of 13 items with two domains; a subscale (5-item) that measures pain, and another subscale (8-item) that assesses disability. Each subscale is added and transformed into a score that ranges from 0 (less shoulder disability) to 100 (more shoulder dysfunction).
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Apr 2023
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- None (open label)
- Enrolment
- 40 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
- NCT05811533
- Sponsor's protocol ID
- REC/MS-PT/01496 Neelam
- Status last verified
- Jul 2023
- First submitted
- 31 Mar 2023
- Last updated
- 19 Jul 2023
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spencer's Muscle Energy Technique and Post-facilitation Stretch in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05811533
- Acronym / sponsor ID
- REC/MS-PT/01496 Neelam
- Conditions
- Frozen Shoulder
- Keywords
- spencer Muscle energy technique, post facilitation, pain, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 13 Apr 2023 (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.
Adhesive capsulitis is one of the most common problems of the upper limb. Adhesive capsulitis (AC) and frozen shoulder syndrome (FSS) are two terms that have been used to describe a painful and stiff shoulder.
Conservative treatment includes transcutaneous electrical nerve stimulation (TENS), Ultrasound, LASER, Range of Motion, stretching and strengthening exercises, patient education, and home exercises. Manual therapy includes mobilization, Spencer's Muscle Energy Technique and Mobilization With Movement.
Detailed description
The American Academy of Orthopedic Surgeons defines this condition as: "A condition of varying severity characterized by the gradual development of global limitation of active and passive shoulder motion where radiographic findings other than osteopenia are absent." Patients with frozen shoulder typically experience insidious shoulder stiffness, severe pain that usually worsens at night, and near-complete loss of passive and active external rotation of the shoulder.
Although spencer's Muscle Energy Technique is a very effective technique, still it was rarely used. It is a standardized series of steps of shoulder treatments with broad application in diagnosis, treatment, and prognosis developed by Spencer in 1961 and is a well-known osteopathic manipulative technique that focuses on mobilization of the glenohumeral and scapulothoracic joints. It is an articulatory technique in which passive, smooth, rhythmic motion of the shoulder joint is done by the therapist to stretch contracted muscles, ligaments, and capsule. Most of the force is applied at the end range of motion. This technique increases pain-free Range of Motion by stretching the tissues, enhancing lymphatic flow, and stimulating increased joint circulation.
On the other hand, "post-facilitation stretch (PFS)" is a muscle energy technique developed by Dr.Vladimir Janda to lengthen chronically shortened muscles that involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a 20-second static stretch. This technique is more aggressive than Post Isometric Relaxation and based on the concept of autogenic inhibition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spencer's MET with conventional therapy | Experimental | Other: Spencer's MET with conventional therapyPatients will be asked to lie in a side lying position with the affected shoulder above. The therapist will stabilize the shoulder girdle with the proximal hand and the distal hand provided force into the restrictive barrier of shoulder in 7 different movements. During all the movements, patients will ask to use their muscle energy 20% against the slight resistance offered by the therapist for 3-5 seconds. The patient then asks to relax and exhale after that shoulder joint will move beyond the barrier to achieve the next barrier. After 20 sec of rest, this technique will be repeated 3-5 times |
| Post-Facilitation Stretch with conventional therapy | Experimental | Other: Post-Facilitation Stretch with conventional therapyMuscle Energy Technique [Post Facilitation Stretch)] for the shoulder joint will be applied with 3 repetitions per set, 1 session per day. Patient will be instructed to perform a full strength contraction of the muscle to be stretch for 10 seconds. The muscle is then allow to fully relax, whereupon a rapid stretch of the affected muscle will be performed and will held in position by the physician for 15 sec. Patient will be asked to relax and whole cycle will be repeated. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with primary unilateral adhesive capsulitis
- Stage II and III adhesive capsulitis
- Patients with limited active and passive Range of Motion of the affected shoulder (globally loss of at least 50% compared to non-involved shoulder in one or more directions)
- Patients with controlled diabetes
Key exclusion criteria (6 listed)
- Patients with a positive history of trauma, fracture, or surgery of the cervical spine
- Corticosteroid injection in the affected shoulder in the preceding 4 weeks.
- Malignancy/Avascular Necrosis of shoulder
- Post-traumatic shoulder stiffness
- Thoracic outlet syndrome/neurological disorder
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 |
|---|---|---|
| Spencer's MET with conventional therapyPatients will be asked to lie in a side lying position with the affected shoulder above. The therapist will stabilize the shoulder girdle with the proximal hand and the distal hand provided force into the restrictive barrier of shoulder in 7 different movements. During all the movements, patients will ask to use their muscle energy 20% against the slight resistance offered by the therapist for 3-5 seconds. The patient then asks to relax and exhale after that shoulder joint will move beyond the barrier to achieve the next barrier. After 20 sec of rest, this technique will be repeated 3-5 times | Other | Spencer's MET with conventional therapy |
| Post-Facilitation Stretch with conventional therapyMuscle Energy Technique [Post Facilitation Stretch)] for the shoulder joint will be applied with 3 repetitions per set, 1 session per day. Patient will be instructed to perform a full strength contraction of the muscle to be stretch for 10 seconds. The muscle is then allow to fully relax, whereupon a rapid stretch of the affected muscle will be performed and will held in position by the physician for 15 sec. Patient will be asked to relax and whole cycle will be repeated | Other | Post-Facilitation Stretch with conventional therapy |
Primary outcome
(Numeric Pain Rating Scale)
Time frame: four weeks
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable
Goniometer
Time frame: four weeks
A goniometer is a device that measures an angle or permits the rotation of an object to a definite position. To measure the range of motion, doctors, osteopaths, physical therapists, or other health professionals most commonly use a goniometer, which is an instrument that measures angle motion at a joint
SPADI (Shoulder Pain and Disability Index)
Time frame: four weeks
The shoulder pain and disability index (SPADI) is also a reliable and valid clinimetric (Cronbach-α>0.90), self-administered questionnaire used by orthopedics and physical therapists for proper assessment of shoulder related pain and disabilities in terms of functional outcomes in patients suffering from different types of the shoulder-related pathologies. It consists of 13 items with two domains; a subscale (5-item) that measures pain, and another subscale (8-item) that assesses disability. Each subscale is added and transformed into a score that ranges from 0 (less shoulder disability) to 100 (more shoulder dysfunction).
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 19 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Frozen 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
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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
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen 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 Spencer's MET with conventional therapy and Post-Facilitation Stretch with conventional therapy in people with Frozen Shoulder, 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 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 19 Jul 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) (time frame: four weeks). 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 19 Jul 2023.