Adhesive CapsulitisNCT05448612
Comparative Effect of ART and MET on Pain, ROM and Functional Disability in AC Patients With Trigger Points
A study testing Active Release Technique and muscle energy technique in people with Adhesive Capsulitis, run by University of Lahore at 1 site in Pakistan.
Trial summary
The aim of this study to determine the Comparative effect of active release technique and muscle energy technique on pain, ROM and functional disability in adhesive capsulitis patients with trigger points. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Active Release Technique and muscle energy technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2022to 30 Sep 2022
- 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
- Both male and female.
- Participants having unilateral adhesive capsulitis.
- Participants with sub-acute adhesive capsulitis.
- Participants having age of 40-60 years.
Who cannot join
- Patient with cervical radiculopathy.
- Fractures of upper limb.
- Thoracic outlet syndrome.
- Post-traumatic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of Active Release Technique and Muscles Energy Technique on Pain, ROM and Functional Disability in Adhesive Capsulitis Patients With Trigger Points
The aim of this study to determine the Comparative effect of active release technique and muscle energy technique on pain, ROM and functional disability in adhesive capsulitis patients with trigger points.
Read the detailed description
74 participants are included in this study in two groups and 37 for each group. Group A for active release technique along with conventional therapy and Group B for muscles energy technique along with conventional therapy.
- Conditions
- Adhesive Capsulitis
- Being tested
- Active Release Technique and muscle energy technique
- Keywords
- Adhesive capsulitis, Trigger points, Active release technique, Muscle 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.
Active Release Technique and muscle energy techniqueOther
74 participants divided into two groups and 37 in each group.
| Study group | Role | What they receive |
|---|---|---|
| Active Release Technique | Experimental | In ART the particular muscle is taken from shortened to lengthened position or vice versa. Duration of treatment will be of 8-15min Receives: Other: Active Release Technique and muscle energy technique |
| Muscles Energy Technique | Experimental | In METs,the protocol will perform for 3 repetitions per day and thrice a week for 5 week. Receives: Other: Active Release Technique and muscle energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale
patients rate their pain from 0 to 10, from 0 to 20, or from 0 to 100. Zero represents "no pain," whereas 10, 20, or 100 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain").
Measured: Change from Baseline in pain to 6 week
Universal Goniometry
Universal goniometer (UG) is commonly used as a standard method to evaluate range of motion (ROM) as part of joint motions.
Measured: Change from Baseline in range of motion to 6 week
Shoulder Pain and Functional Disability Index
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire consisting of items grouped into pain and disability subscales.
Measured: Change from Baseline in disability to 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start10 Jan 2022
- Primary completion25 Feb 2022
- Study completion30 Sep 2022 (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 University of LahoreThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahzadi Sumbal Naz, Dpt, Study chair, UOL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448612
- Sponsor's protocol ID
- REC-UOL-/98-04/2022
- Status last verified
- May 2022
- First submitted
- 22 May 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Active Release Technique and Muscles Energy Technique on Pain, ROM and Functional Disability in Adhesive Capsulitis Patients With Trigger Points
- ClinicalTrials.gov ID
- NCT05448612
- Acronym / sponsor ID
- REC-UOL-/98-04/2022
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive capsulitis, Trigger points, Active release technique, Muscle energy technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 7 Jul 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 aim of this study to determine the Comparative effect of active release technique and muscle energy technique on pain, ROM and functional disability in adhesive capsulitis patients with trigger points.
Detailed description
74 participants are included in this study in two groups and 37 for each group. Group A for active release technique along with conventional therapy and Group B for muscles energy technique along with conventional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Release Technique | Experimental | Other: Active Release Technique and muscle energy techniqueIn ART the particular muscle is taken from shortened to lengthened position or vice versa. Duration of treatment will be of 8-15min |
| Muscles Energy Technique | Experimental | Other: Active Release Technique and muscle energy techniqueIn METs,the protocol will perform for 3 repetitions per day and thrice a week for 5 week. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both male and female.
- Participants having unilateral adhesive capsulitis.
- Participants with sub-acute adhesive capsulitis.
- Participants having age of 40-60 years.
Key exclusion criteria (4 listed)
- Patient with cervical radiculopathy.
- Fractures of upper limb.
- Thoracic outlet syndrome.
- Post-traumatic.
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 |
|---|---|---|
| Active Release Technique and muscle energy technique74 participants divided into two groups and 37 in each group. | Other | Active Release Technique, Muscles Energy Technique |
Primary outcome
Numerical pain rating scale
Time frame: Change from Baseline in pain to 6 week
patients rate their pain from 0 to 10, from 0 to 20, or from 0 to 100. Zero represents "no pain," whereas 10, 20, or 100 represents the opposite end of the pain continuum (e.g., "the most intense pain imaginable," "pain as intense as it could be," "maximum pain").
Universal Goniometry
Time frame: Change from Baseline in range of motion to 6 week
Universal goniometer (UG) is commonly used as a standard method to evaluate range of motion (ROM) as part of joint motions.
Shoulder Pain and Functional Disability Index
Time frame: Change from Baseline in disability to 6 week
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire consisting of items grouped into pain and disability subscales.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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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.
Shahzadi Sumbal Naz, Dpt study chair
UOL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Release Technique and muscle energy technique in people with Adhesive Capsulitis, run by University of Lahore 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 4 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 7 Jul 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 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?
Numerical pain rating scale (time frame: Change from Baseline in pain to 6 week). 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 7 Jul 2022.