Adhesive CapsulitisNCT05889065
Effects of Scapular Proprioceptive Neuromuscular Facilitation on Pain and Range of Motion in Patients With Adhesive Capsulitis
A study testing Conventional Physical Therapy and PNF techniques in people with Adhesive Capsulitis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The term ''frozen shoulder'' is defined as a clinical condition with restricted active and passive range of motion (ROM) in all directions, including flexion, abduction, and rotation.The objective of the study is to determine the effects of Scapular proprioceptive neuromuscular facilitation and conventional physical… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Conventional Physical Therapy and PNF techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 1 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases diagnosed with adhesive capsulitis, both primary and secondary origin.
- Stage two and stage three of adhesive capsulitis.
- Unilateral adhesive capsulitis.
- Both males and females of the age group 40 years and above.
Who cannot join
- History of shoulder surgery or manipulation under anesthesia,
- Local corticosteroid injection administration to the affected shoulder within the last 3 months.
- Severe musculoskeletal, neurological and cardiovascular conditions.
Trial locations and contacts
1 site in 1 country.
About this study
The term ''frozen shoulder'' is defined as a clinical condition with restricted active and passive range of motion (ROM) in all directions, including flexion, abduction, and rotation.The objective of the study is to determine the effects of Scapular proprioceptive neuromuscular facilitation and conventional physical therapy among patients with adhesive capsulitis.The study will be a randomized controlled trial (single-blinded parallel study), consisting of 2 groups- interventional group A and interventional group B.Group A will be given conventional physical therapy and group B will be given conventional physical therapy alongwith scapular PNF.Scapular PNF exercises are not included in our routine PT treatment programs and there is limited literature related to the PNF techniques. These techniques help develop muscular strength and endurance, joint stability, mobility, neuromuscular control and coordination all of which are aimed at improving the overall functional ability of patients.
- Conditions
- Adhesive Capsulitis
- Being tested
- Conventional Physical Therapy, PNF techniques
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical TherapyProcedure or surgery
group A will receive conventional physical therapy including
10
ultrasound(1.5w/cm2
,3 MHz continuous type, duration 10 minutes),hot packs (on affected region of shoulder for 10 minutes),shoulder ROM, stretching exercises, and joint mobilization five times per week for two weeks with 40 minutes duration of each session. Maitland mobilization will be given in supine position.
- After giving glenohumeral joint distraction, caudal, dorsal, and ventral glides will be given at a rate of 2-3 oscillation/second for 1 to 2 minutes to patients. Grade I or II rhythmic oscillations will be applied in free range.
PNF techniquesProcedure or surgery
In this group 20 repetitions of diagonal scapular pattern (anterior elevation and posterior depression, posterior elevation and anterior depression) with 20 seconds rest period will be given to subjects. PNF techniques of rhythmic initiation and repeated contractions will be used in all patterns, applied for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Conventional PT Group | Active comparator | Conventional group will receive routine physical therapy including
10
ultrasound(1.5w/cm2
,3 MHz continuous type, duration 10 minutes),hot packs (on affected region of shoulder for 10 minutes),shoulder ROM, stretching exercises, and joint mobilization five times per week for two weeks with 40 minutes duration of each session. Maitland mobilization will be given in supine position.
· After giving glenohumeral joint distraction, caudal, dorsal, and ventral glides will be given at a rate of 2-3 oscillation/second for 1 to 2 minutes to patients. Grade I or II rhythmic oscillations will be applied in free range. Receives: Procedure: Conventional Physical Therapy |
| Scapular PNF + Conventional PT Group | Experimental | This group will receive scapular PNF techniques along with routine physical therapy (same as above). In this group 20 repetitions of diagonal scapular pattern (anterior elevation and posterior depression, posterior elevation and anterior depression) with 20 seconds rest period will be given to subjects. PNF techniques of rhythmic initiation and repeated contractions will be used in all patterns, applied for 40 minutes. Receives: Procedure: Conventional Physical Therapy; Procedure: PNF techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain
Shoulder Pain will be measured on the basis of visual analogue scale of 0-100mm. A higher score signifies greater pain.
Measured: 2 weeks
Secondary outcomes (2)
Shoulder range of motion (ROM)
Shoulder range of motion (ROM) will be measured through goniometer. A higher score signifies greater range.
Measured: 2 weeks
Scapular mobility
scapular mobility will be measured through lateral slide test (LSST)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Aug 2022
- Primary completion15 Jun 2023 (estimated)
- Study completion1 Jul 2023 (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. One group will receive conventional physical therapy and the other group will receive scapular PNF with conventional physical therapy. Both groups will be recruited concurrently.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryum Fatima, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889065
- Sponsor's protocol ID
- FUI/CTR/2023/8
- Status last verified
- May 2023
- First submitted
- 25 May 2023
- Last updated
- 5 Jun 2023
- 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 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scapular Proprioceptive Neuromuscular Facilitation on Pain and Range of Motion in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05889065
- Acronym / sponsor ID
- FUI/CTR/2023/8
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 5 Jun 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.
The term ''frozen shoulder'' is defined as a clinical condition with restricted active and passive range of motion (ROM) in all directions, including flexion, abduction, and rotation.The objective of the study is to determine the effects of Scapular proprioceptive neuromuscular facilitation and conventional physical therapy among patients with adhesive capsulitis.The study will be a randomized controlled trial (single-blinded parallel study), consisting of 2 groups- interventional group A and interventional group B.Group A will be given conventional physical therapy and group B will be given conventional physical therapy alongwith scapular PNF.Scapular PNF exercises are not included in our routine PT treatment programs and there is limited literature related to the PNF techniques. These techniques help develop muscular strength and endurance, joint stability, mobility, neuromuscular control and coordination all of which are aimed at improving the overall functional ability of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the other group will receive scapular PNF with conventional physical therapy. Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Conventional PT Group | Active comparator | Procedure: Conventional Physical TherapyConventional group will receive routine physical therapy including 10 ultrasound(1.5w/cm2 ,3 MHz continuous type, duration 10 minutes),hot packs (on affected region of shoulder for 10 minutes),shoulder ROM, stretching exercises, and joint mobilization five times per week for two weeks with 40 minutes duration of each session. Maitland mobilization will be given in supine position. · After giving glenohumeral joint distraction, caudal, dorsal, and ventral glides will be given at a rate of 2-3 oscillation/second for 1 to 2 minutes to patients. Grade I or II rhythmic oscillations will be applied in free range. |
| Scapular PNF + Conventional PT Group | Experimental | Procedure: Conventional Physical Therapy, Procedure: PNF techniquesThis group will receive scapular PNF techniques along with routine physical therapy (same as above). In this group 20 repetitions of diagonal scapular pattern (anterior elevation and posterior depression, posterior elevation and anterior depression) with 20 seconds rest period will be given to subjects. PNF techniques of rhythmic initiation and repeated contractions will be used in all patterns, applied for 40 minutes. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cases diagnosed with adhesive capsulitis, both primary and secondary origin.
- Stage two and stage three of adhesive capsulitis.
- Unilateral adhesive capsulitis.
- Both males and females of the age group 40 years and above.
Key exclusion criteria (3 listed)
- History of shoulder surgery or manipulation under anesthesia,
- Local corticosteroid injection administration to the affected shoulder within the last 3 months.
- Severe musculoskeletal, neurological and cardiovascular conditions.
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 |
|---|---|---|
| Conventional Physical Therapygroup A will receive conventional physical therapy including 10 ultrasound(1.5w/cm2 ,3 MHz continuous type, duration 10 minutes),hot packs (on affected region of shoulder for 10 minutes),shoulder ROM, stretching exercises, and joint mobilization five times per week for two weeks with 40 minutes duration of each session. Maitland mobilization will be given in supine position. · After giving glenohumeral joint distraction, caudal, dorsal, and ventral glides will be given at a rate of 2-3 oscillation/second for 1 to 2 minutes to patients. Grade I or II rhythmic oscillations will be applied in free range. | Procedure or surgery | Conventional PT Group, Scapular PNF + Conventional PT Group |
| PNF techniquesIn this group 20 repetitions of diagonal scapular pattern (anterior elevation and posterior depression, posterior elevation and anterior depression) with 20 seconds rest period will be given to subjects. PNF techniques of rhythmic initiation and repeated contractions will be used in all patterns, applied for 40 minutes. | Procedure or surgery | Scapular PNF + Conventional PT Group |
Primary outcome
Shoulder Pain
Time frame: 2 weeks
Shoulder Pain will be measured on the basis of visual analogue scale of 0-100mm. A higher score signifies greater pain.
2 secondary outcomes
Shoulder range of motion (ROM)
Time frame: 2 weeks
Scapular mobility
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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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.
Maryum Fatima principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy and PNF techniques 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 4 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: status not confirmed, as of the sponsor's last update on 5 Jun 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?
Results are not available in the source record.
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?
Shoulder Pain (time frame: 2 weeks). 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 5 Jun 2023.