Frozen ShoulderNCT06567288
Effect of Spencer Muscle Energy Technique on Pain in Diabetic Stiff Shoulder
A study testing spencer mscle energy technique in people with Frozen Shoulder, run by Cairo University.
Trial summary
Stiff shoulder is a painful and severely debilitating condition. The inflammatory contracture of the glenohumeral joint capsule in stiff shoulder restricts both active and passive range of motion, with loss of external rotation being especially characteristic of this condition (Dyer et al., 2023). Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- spencer mscle energy technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Dec 2024
- 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1) Women's age between 45 to 55 years old 2)Suffering from stiff shoulder for 2-12 months (stage 1 and 2) confirmed by an orthopaedic specialist.
- 3) Diagnosed as type 2 DM for at least 5 years. 4) No treatment other than analgesics
Who cannot join
- 1. cases of traumatic stiff shoulder. 2. Osteoporosis and malignance of shoulder region. 3. Neurological deficit affect shoulder function. 4. rheumatoid arthritis. 5. recurrent subluxation of shoulder. 6. cervical radiculopathy. 7. history of shoulder surgery. 8. vascular diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effeect of Spencer Muscle Energy Technique on Pain in Diabetic Stiff Shoulder
Stiff shoulder is a painful and severely debilitating condition. The inflammatory contracture of the glenohumeral joint capsule in stiff shoulder restricts both active and passive range of motion, with loss of external rotation being especially characteristic of this condition (Dyer et al., 2023). Stiff shoulder is clinically described by the continuing onset of shoulder pain and advanced exacerbation of the shoulder joint leading to exertion in the higher extremity activity, significant disability, and functional restrictions. The most common symptom of a stiff shoulder is night pain, resulting in sleep impediment that leads to one-sided sleep on the uninfected shoulder (Mao et al., 2022).
Spencer technique is a standardized series of treatments with broad application to diagnose, treat and establish prognosis for restricted mobility in shoulder. It was developed by Spencer in 1961. It is a multistep technique that combines Spencer's positioning, sequencing, slow stretching of the shoulder complex within pain-free limits done by physical therapist while incorporating muscular energy with post-isometric contraction and relaxation (Babu And Putcha., 2022).
Read the detailed description
thirty diabetic female patients with Stiff shoulder with ages 45-55 years:
Group A(study group) :
15 patients received Spencer Muscle Energy Technique along with postural exercise 3 times a week for 8 week.
Group B (control group) :
15 patients received Classical physiotherapy treatment includes Transcutaneous Electrical Nerve Stimulation (TENS) for 15 minutes hotpack on the painful area for 15 minutes along with postural exercise 3 times per week for 8 week.
- Conditions
- Frozen Shoulder
- Being tested
- spencer mscle 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.
spencer mscle energy techniqueProcedure or surgery
Also called spencer MET
The effectiveness of MET found in chronic capsulitis is due to its effect on relieving pain, ensuring ROM incretions, and developing functional activities due to the muscle contraction in a precise direction and in a monitored position over resistance to assist in improving joint range by advancing joint flexibility. This procedure is suggested for all joints with limited ROM (Butt \& Tanveer, 2022).
| Study group | Role | What they receive |
|---|---|---|
| spencer muscle energy technique | Experimental | Spencer muscle energy technique (SMET) attempts to re-establish functional relationship between soft and articular tissues of the shoulder region, minimizes inflammatory and later developing fibrotic process, and restores arterial, venous, and lymphatic flow. Like other OMT procedures, it not only restores joint functions, but enhances positive well-being and full expression of a patient's life. In this technique, passive, smooth, rhythmic motion of the shoulder joint is done by the therapist to stretch contracted muscles, ligaments, and capsule (Babu And Putcha.,2022). Receives: Procedure: spencer mscle energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain pressure threshold algometry
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold.
Measured: will be measured at baseline, and it will be measured after eight weeks
Visual Analogue Scale (VAS)
was used to assess the severity of pain before and after treatment for both groups
Measured: will be measured at baseline, and it will be measured after eight weeks
Secondary outcomes (2)
goniometer
measures the available range of motion
Measured: will be measured at baseline, and it will be measured after eight weeks
SPADI (shoulder pain and disability index).
It is a self-revealed measure created to assess shoulder pathological conditions
Measured: will be measured at baseline, and it will be measured after eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed El-Moatasem Mohamed, Cairo University
- Investigators
- NESREEN GHAREEB, Vice Dean, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567288
- Sponsor's protocol ID
- P.T.REC/012/004908
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effeect of Spencer Muscle Energy Technique on Pain in Diabetic Stiff Shoulder
- ClinicalTrials.gov ID
- NCT06567288
- Acronym / sponsor ID
- P.T.REC/012/004908
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 22 Aug 2024 (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.
Stiff shoulder is a painful and severely debilitating condition. The inflammatory contracture of the glenohumeral joint capsule in stiff shoulder restricts both active and passive range of motion, with loss of external rotation being especially characteristic of this condition (Dyer et al., 2023). Stiff shoulder is clinically described by the continuing onset of shoulder pain and advanced exacerbation of the shoulder joint leading to exertion in the higher extremity activity, significant disability, and functional restrictions. The most common symptom of a stiff shoulder is night pain, resulting in sleep impediment that leads to one-sided sleep on the uninfected shoulder (Mao et al., 2022).
Spencer technique is a standardized series of treatments with broad application to diagnose, treat and establish prognosis for restricted mobility in shoulder. It was developed by Spencer in 1961. It is a multistep technique that combines Spencer's positioning, sequencing, slow stretching of the shoulder complex within pain-free limits done by physical therapist while incorporating muscular energy with post-isometric contraction and relaxation (Babu And Putcha., 2022).
Detailed description
thirty diabetic female patients with Stiff shoulder with ages 45-55 years:
Group A(study group) :
15 patients received Spencer Muscle Energy Technique along with postural exercise 3 times a week for 8 week.
Group B (control group) :
15 patients received Classical physiotherapy treatment includes Transcutaneous Electrical Nerve Stimulation (TENS) for 15 minutes hotpack on the painful area for 15 minutes along with postural exercise 3 times per week for 8 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spencer muscle energy technique | Experimental | Procedure: spencer mscle energy techniqueSpencer muscle energy technique (SMET) attempts to re-establish functional relationship between soft and articular tissues of the shoulder region, minimizes inflammatory and later developing fibrotic process, and restores arterial, venous, and lymphatic flow. Like other OMT procedures, it not only restores joint functions, but enhances positive well-being and full expression of a patient's life. In this technique, passive, smooth, rhythmic motion of the shoulder joint is done by the therapist to stretch contracted muscles, ligaments, and capsule (Babu And Putcha.,2022). |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1) Women's age between 45 to 55 years old 2)Suffering from stiff shoulder for 2-12 months (stage 1 and 2) confirmed by an orthopaedic specialist.
- 3) Diagnosed as type 2 DM for at least 5 years. 4) No treatment other than analgesics
Key exclusion criteria (1 listed)
- 1. cases of traumatic stiff shoulder. 2. Osteoporosis and malignance of shoulder region. 3. Neurological deficit affect shoulder function. 4. rheumatoid arthritis. 5. recurrent subluxation of shoulder. 6. cervical radiculopathy. 7. history of shoulder surgery. 8. vascular diseases.
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 mscle energy techniqueAlso: spencer METThe effectiveness of MET found in chronic capsulitis is due to its effect on relieving pain, ensuring ROM incretions, and developing functional activities due to the muscle contraction in a precise direction and in a monitored position over resistance to assist in improving joint range by advancing joint flexibility. This procedure is suggested for all joints with limited ROM (Butt \& Tanveer, 2022). | Procedure or surgery | spencer muscle energy technique |
Primary outcome
pain pressure threshold algometry
Time frame: will be measured at baseline, and it will be measured after eight weeks
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold.
Visual Analogue Scale (VAS)
Time frame: will be measured at baseline, and it will be measured after eight weeks
was used to assess the severity of pain before and after treatment for both groups
2 secondary outcomes
goniometer
Time frame: will be measured at baseline, and it will be measured after eight weeks
SPADI (shoulder pain and disability index).
Time frame: will be measured at baseline, and it will be measured after eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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.
NESREEN GHAREEB, Vice Dean principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
A study testing spencer mscle energy technique in people with Frozen Shoulder, run by Cairo University.
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 1 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Alaa El-moatasem, lecturer (01006625054, alaamotasem@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain pressure threshold algometry (time frame: will be measured at baseline, and it will be measured after eight 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 22 Aug 2024.