Adhesive CapsulitisNCT06668415
Effects of Spencer Technique Following Hydrodilation in Patients With Adhesive Capsulitis
A study testing Hydro dilation, Spencer muscle energy technique and Passive Stretching in people with Adhesive Capsulitis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Adhesive Capsulitis is a common Musculoskeletal disorder characterized by pain and progressive joint restriction in capsular pattern. Adhesive capsulitis can be managed by both conservative and non conservative treatment. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Hydro dilation, Spencer muscle energy technique and Passive Stretching
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jul 2024to 31 Oct 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosed unilateral Adhesive Capsulitis and have undergone Hydrodilation. --Includes both genders
- Age 40 to 60 years. Exclusion Criteria
- Population who have recently undergone major shoulder injury or surgery, had fracture or open wound or there is reduction of Glen humeral ROM due to any other cause other than Adhesive Capsulitis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Furqan Yaqoob, PhD*, +923465333101, furqan.yaqoob@fui.edu.pk
About this study
Adhesive Capsulitis is a common Musculoskeletal disorder characterized by pain and progressive joint restriction in capsular pattern. Adhesive capsulitis can be managed by both conservative and non conservative treatment. The Spencer technique and hydrodilation are two treatment approaches used to restore range of motion in adhesive capsulitis.
The Spencer technique is a form of physical therapy that involves joint mobilizations and manual stretching exercises. It aims to improve shoulder mobility and reduce pain by addressing the tightness and stiffness in the shoulder capsule and surrounding tissues.
Hydrodilation, on the other hand, is a procedure where a saline solution is injected into the shoulder joint to distend the capsule. This distention helps stretch the tight tissues and break up adhesions, facilitating improved range of motion.
Read the detailed description
Adhesive capsulitis, also subsequently known as Frozen shoulder is a musculoskeletal disorder characterized by painful and progressive joint restriction in capsular pattern. It has a prevalence of 2 to 5% in general population and the incidence is more in females mostly aged 40 to 60 years mostly suffering from Diabetes Mellitus. Adhesive Capsulitis can be classified into three phases; Freezing (painful), Frozen (stiffening) and Thawing (resolution phase). The treatment protocol is planned such to improve the range of motion and reduce pain. Various treatment regimes are followed for treatment of adhesive capsulitis, either it be in medical field, physical therapy or in worst cases surgical treatments too.
Hydrodilation, a medical procedure which involves injecting a fluid (mainly normal saline) into the joint space which expands the space breaking up scar tissue and loosening the joint. This method is being widely used in isolation or in combination with other methods to treat Adhesive capsulitis.
Spencer technique on another hand is a physical therapy technique which in isolation or in conjunction with other treatments is used to treat patients with adhesive capsulitis. Spencer muscle energy technique is a seven 7 step procedure which consists of shoulder extension with elbow flexed, shoulder flexion with elbow flexed, circumduction with compression, circumduction with traction, Abduction then adduction with external rotation and glenohumeral pump.
Hence the current study will investigate the effects of Spencer technique following hydrodilation in patients with Adhesive Capsulitis.
The study includes subjects with unilateral adhesive capsulitis, 40-60 years of age both male and female and have undergone Hydrodilation. The selction of subjects will be using non probability purposive sampling technique. Participants will be randomized using sealed envelope method and allocated to one of two groups.
The data collection tool for pain is VAS, for ROM is Goniometer and for disability is SPADI.
The time duration for treatment protocol is total of 12 sessions, 3 sessions per week. Exercise is done 3 to 5 times with rest periods.
- Conditions
- Adhesive Capsulitis
- Being tested
- Hydro dilation, Spencer muscle energy technique, Passive Stretching
- Keywords
- Hydrodilation, spencer technique, pain, functional disability, 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.
Hydro dilationProcedure or surgery
The hydro dilation injections comprises of Depomedrol 80mg and normal saline 0.9%. It is performed under fluoroscopic guidance by the orthopedic surgeon.
Spencer muscle energy techniqueProcedure or surgery
Spencer muscle energy technique is a seven 7 step procedure which consists of shoulder extension with elbow flexed, shoulder flexion with elbow flexed, circumduction with compression, circumduction with traction, Abduction then adduction with external rotation and glenohumeral pump. Following the complete action, patients will be encouraged to use their muscles for 3 to 5 seconds against little resistance provided by the therapist
Passive StretchingProcedure or surgery
The low intensity stretches will be given in supine for all the movements ie Flexion ,Abduction , Internal Rotation and External Rotation for 5 repititions with 30 sec hold.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Hydrodilation+Spencer Technique ) | Active comparator | Patients in this group will be followed by Spencer Technique after Hydrodilation for the duration of 4 weeks which includes 12 sessions in total. Spencer muscle energy technique is a seven 7 step procedure which consists of shoulder extension with elbow flexed, shoulder flexion with elbow flexed, circumduction with compression, circumduction with traction, Abduction then adduction with external rotation and glenohumeral pump. Following the complete action, patients will be encouraged to use their muscles for 3 to 5 seconds against little resistance provided by the therapist Receives: Procedure: Hydro dilation; Procedure: Spencer muscle energy technique |
| Group B (Hydro dilation+ Passive Stretching) | Experimental | This group will undergo Passive Stretching followed by Hydrodilation. The low intensity stretches will be given in supine for all the movements ie Flexion ,Abduction , Internal Rotation and External Rotation for 5 repititions with 30 sec hold. (7) Receives: Procedure: Hydro dilation; Procedure: Passive Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder ROM
Range of Motion will be measured using the universal Goniometer which is 0 to 180 degree for half circle model or 0 to 360 degree for full circle models.
Measured: 4 weeks
Pain Intensity
Pain will be assessed using Visual Analog scale which is 0-100 item scale.
Measured: 04 Weeks
Secondary outcomes (1)
Shoulder Disability
Shoulder Disability will be assessed using shoulder pain and disability index.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start20 Jul 2024
- Primary completion1 Oct 2024
- Study completion31 Oct 2024 (estimated)
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 Foundation University IslamabadThe 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
- Model description
- This is a randomized controlled trial having two groups. Both groups; Group A and B will undergo Hydrodilation but Group A will be followed by Spencer Technique whereas Group B will be followed by Passive Stretching.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668415
- Sponsor's protocol ID
- FUI/CTR/2024/47
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spencer Technique Following Hydrodilation in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06668415
- Acronym / sponsor ID
- FUI/CTR/2024/47
- Conditions
- Adhesive Capsulitis
- Keywords
- Hydrodilation, spencer technique, pain, functional disability, range of motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 31 Oct 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.
Adhesive Capsulitis is a common Musculoskeletal disorder characterized by pain and progressive joint restriction in capsular pattern. Adhesive capsulitis can be managed by both conservative and non conservative treatment. The Spencer technique and hydrodilation are two treatment approaches used to restore range of motion in adhesive capsulitis.
The Spencer technique is a form of physical therapy that involves joint mobilizations and manual stretching exercises. It aims to improve shoulder mobility and reduce pain by addressing the tightness and stiffness in the shoulder capsule and surrounding tissues.
Hydrodilation, on the other hand, is a procedure where a saline solution is injected into the shoulder joint to distend the capsule. This distention helps stretch the tight tissues and break up adhesions, facilitating improved range of motion.
Detailed description
Adhesive capsulitis, also subsequently known as Frozen shoulder is a musculoskeletal disorder characterized by painful and progressive joint restriction in capsular pattern. It has a prevalence of 2 to 5% in general population and the incidence is more in females mostly aged 40 to 60 years mostly suffering from Diabetes Mellitus. Adhesive Capsulitis can be classified into three phases; Freezing (painful), Frozen (stiffening) and Thawing (resolution phase). The treatment protocol is planned such to improve the range of motion and reduce pain. Various treatment regimes are followed for treatment of adhesive capsulitis, either it be in medical field, physical therapy or in worst cases surgical treatments too.
Hydrodilation, a medical procedure which involves injecting a fluid (mainly normal saline) into the joint space which expands the space breaking up scar tissue and loosening the joint. This method is being widely used in isolation or in combination with other methods to treat Adhesive capsulitis.
Spencer technique on another hand is a physical therapy technique which in isolation or in conjunction with other treatments is used to treat patients with adhesive capsulitis. Spencer muscle energy technique is a seven 7 step procedure which consists of shoulder extension with elbow flexed, shoulder flexion with elbow flexed, circumduction with compression, circumduction with traction, Abduction then adduction with external rotation and glenohumeral pump.
Hence the current study will investigate the effects of Spencer technique following hydrodilation in patients with Adhesive Capsulitis.
The study includes subjects with unilateral adhesive capsulitis, 40-60 years of age both male and female and have undergone Hydrodilation. The selction of subjects will be using non probability purposive sampling technique. Participants will be randomized using sealed envelope method and allocated to one of two groups.
The data collection tool for pain is VAS, for ROM is Goniometer and for disability is SPADI.
The time duration for treatment protocol is total of 12 sessions, 3 sessions per week. Exercise is done 3 to 5 times with rest periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. Both groups; Group A and B will undergo Hydrodilation but Group A will be followed by Spencer Technique whereas Group B will be followed by Passive Stretching.
| Arm | Type | Receives |
|---|---|---|
| Group A (Hydrodilation+Spencer Technique ) | Active comparator | Procedure: Hydro dilation, Procedure: Spencer muscle energy techniquePatients in this group will be followed by Spencer Technique after Hydrodilation for the duration of 4 weeks which includes 12 sessions in total. Spencer muscle energy technique is a seven 7 step procedure which consists of shoulder extension with elbow flexed, shoulder flexion with elbow flexed, circumduction with compression, circumduction with traction, Abduction then adduction with external rotation and glenohumeral pump. Following the complete action, patients will be encouraged to use their muscles for 3 to 5 seconds against little resistance provided by the therapist |
| Group B (Hydro dilation+ Passive Stretching) | Experimental | Procedure: Hydro dilation, Procedure: Passive StretchingThis group will undergo Passive Stretching followed by Hydrodilation. The low intensity stretches will be given in supine for all the movements ie Flexion ,Abduction , Internal Rotation and External Rotation for 5 repititions with 30 sec hold. (7) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with diagnosed unilateral Adhesive Capsulitis and have undergone Hydrodilation. --Includes both genders
- Age 40 to 60 years. Exclusion Criteria
- Population who have recently undergone major shoulder injury or surgery, had fracture or open wound or there is reduction of Glen humeral ROM due to any other cause other than Adhesive Capsulitis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hydro dilationThe hydro dilation injections comprises of Depomedrol 80mg and normal saline 0.9%. It is performed under fluoroscopic guidance by the orthopedic surgeon. | Procedure or surgery | Group A (Hydrodilation+Spencer Technique ), Group B (Hydro dilation+ Passive Stretching) |
| Spencer muscle energy techniqueSpencer muscle energy technique is a seven 7 step procedure which consists of shoulder extension with elbow flexed, shoulder flexion with elbow flexed, circumduction with compression, circumduction with traction, Abduction then adduction with external rotation and glenohumeral pump. Following the complete action, patients will be encouraged to use their muscles for 3 to 5 seconds against little resistance provided by the therapist | Procedure or surgery | Group A (Hydrodilation+Spencer Technique ) |
| Passive StretchingThe low intensity stretches will be given in supine for all the movements ie Flexion ,Abduction , Internal Rotation and External Rotation for 5 repititions with 30 sec hold. | Procedure or surgery | Group B (Hydro dilation+ Passive Stretching) |
Primary outcome
Shoulder ROM
Time frame: 4 weeks
Range of Motion will be measured using the universal Goniometer which is 0 to 180 degree for half circle model or 0 to 360 degree for full circle models.
Pain Intensity
Time frame: 04 Weeks
Pain will be assessed using Visual Analog scale which is 0-100 item scale.
1 secondary outcome
Shoulder Disability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydro dilation, Spencer muscle energy technique and Passive Stretching in people with Adhesive Capsulitis, run by Foundation University Islamabad 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 0 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 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javeria Ilyas, MS-MSKPT* (+923335888256, javeria.ilyas95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder ROM (time frame: 4 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 31 Oct 2024.