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Adhesive CapsulitisNCT05402540

Effectiveness of SCS Technique Verses ART in Adhesive Capsulitis

A study testing STRAIN COUNTER STRAIN GROUP and ACTIVE RELESAE TECHNIQUE GROUP in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To find out the effectiveness of Strain Counter strain Technique verses Active Release Technique on upper trapezius, subscapularis, anterior fiber of deltoid and supraspinatus muscles trigger points in adhesive capsulitis in term of pain intensity, range of motion and muscle strength. 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?
STRAIN COUNTER STRAIN GROUP and ACTIVE RELESAE TECHNIQUE GROUP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
14 Sep 2022to 2 Apr 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

  • Idiopathic Adhesive Capsulitis (AC)
  • Stage 2 AC
  • Both genders
  • ROM limitation in capsular pattern
  • AC having myofascial trigger points in upper trapezius, subscapularis, anterior fibers of deltoid and supraspinatus muscle

Who cannot join

  • Cervical Radiculopathies
  • Thoracic outlet syndrome
  • Rotator cuff tear
  • Diabetes mellitus.
  • Patients with any neurological disorder like hemiplegia.
  • Fracture in and around shoulder

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Bacha Khan Medical Complex Swabi (BKMCS) and District Headquarter Hospital (DHQ) Swabi.

    Swabi

Other trials in Pakistan

About this study

Official title: Effectiveness of Strain Counter Strain Technique Verses Active Release Technique in Adhesive Capsulitis

To find out the effectiveness of Strain Counter strain Technique verses Active Release Technique on upper trapezius, subscapularis, anterior fiber of deltoid and supraspinatus muscles trigger points in adhesive capsulitis in term of pain intensity, range of motion and muscle strength.

Read the detailed description

Frozen shoulder, also known as adhesive capsulitis, is defined as "a condition of uncertain aetiology, characterized by significant restriction of both active and passive shoulder motion that occurs in the absence of a known intrinsic shoulder disorder". Prevalence ranges from 2% to 5% in general population. It is relatively more common in women than men, often in non-dominant arm and age between 40 and 60 years. Frozen shoulder was also termed as adhesive capsulitis (AC) due to its chronic inflammatory process. Painful stiffness of the shoulder can adversely affect activities of daily living and consequently impair quality of life. Adhesive capsulitis can be primary or secondary. Primary (or idiopathic) adhesive capsulitis can occur spontaneously without any specific trauma or inciting event. Secondary adhesive capsulitis is often observed after periarticular fracture dislocation of the glenohumeral joint or other severe articular trauma.

Dr. Lawrence Jones, an osteopathic physician, is credited with the discovery of the therapy; he initially called it Positional release technique (PRT) and later coined the term strain counterstrain. Originally termed strain-counterstrain, is a therapeutic technique that uses trigger points (TrPs) and a position of comfort (POC) to resolve the associated dysfunction. A gentle and passive technique, SCS has been advocated for the treatment of acute, subacute and chronic dysfunction in people of all ages.A number of studies have reported the use of strain/counterstrain in combination with other interventions for treating a variety of disorders, including chondromalacia patellae, low back pain, and cervicothoracic pain.

Active Release Techniques (ART) is a soft tissue method that focuses on relieving tissue tension via the removal of fibrosis/adhesions which can develop in tissues as a result of overload due to repetitive use. The goals of ART are to restore optimal tissue texture, tension and movement, restore the strength, flexibility, function, and relative translation between soft tissue layers, release any soft tissue restrictions, entrapped nerve, restricted circulatory structures, or lymphatic restrictions. ART is used to find the specific tissues that are restricted, physically work on the soft tissues back to their normal texture, tension, and length by using various hand positions and soft tissue manipulation methods.

Active release technique and capsular stretch with conventional therapy is more effective in increasing ROM and decreasing pain of frozen shoulder rather alone capsular stretch with conventional therapy. These changes are clinically significant. Both positional release and muscle energy techniques were shown to be effective in improving functional ability of shoulder in Adhesive Capsulitis, but muscle energy technique was better than positional release technique..Both ART and SCS technique play important role in decreasing hamstring tightness but Active Release Technique is more effective physiotherapeutic intervention than strain counterstrain technique in reducing hamstrings tightness instantly.

Active Release Techniqueand Strain Counterstrain have been proved to be effective in many conditions like low back pain, chronic neck pain, tennis elbow, CTS and shoulder pain. ART and SCS has also been proved effective in treating upper trapezius, subscapularis SCM, hamstring muscle trigger point in comparison with other treatment protocol. But there is limited studies done on comparing these two techniques i.e ART and SCS for the adhesive capsulitis and specifically the use of ART and SCS for AC induced trigger points in different muscles of shoulder. Hence, the aim of present study is to compare the effectiveness of Active release technique and Strain counterstrain technique in adhesive capsulitis induce trigger points in different shoulder muscle in term of pain, ROM and muscle strength.

Being tested
STRAIN COUNTER STRAIN GROUP, ACTIVE RELESAE TECHNIQUE GROUP
Keywords
ADHESIVE CAPSULITIS, SHOULDER PAIN, Range of Motion, Shoulder Muscle Strength
Medical subject headings
Bursitis, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STRAIN COUNTER STRAIN GROUPOther

    Strain Counterstrain Technique in combination with conventional physiotherapy (Hot pack, Codman"s exercises, active assisted exercises, Pendulum exercises, Finger Ladder Exercise, Maitland mobilization of shoulder joint.

    Therapist palpate surrounding and opposing tissues to locate trigger point by using one or two finger pads to monitor fasciculation and MTrP.

    Hold the POC (position of comfort) until fasciculation decreases significantly or ceases. Average positions hold time while pressure is 90 s to 3 min.

    Release tissue or joint slowly and reassess. Each patient will receive total 6 sessions (3sessions/week) over a period of 2 weeks.

    Assessment would be done on baseline and after every three sessions.

  • ACTIVE RELESAE TECHNIQUE GROUPOther

    Active Release Technique in combination with conventional physiotherapy (Hot pack, Codman"s exercises, active assisted exercises, Pendulum exercises, Finger Ladder Exercise, Maitland mobilization of shoulder joint.

    The targeted muscle will be palpated while the therapist will looks for localized tenderness or trigger points with referred pain elicitation.

    With the thumb therapist will relieve the trigger point. In ART the particular muscle is taken from shortened to lengthened position or from lengthened to shortened position.

    Duration of treatment will be 8-15 minutes. Each patient will receive total 6 sessions (3sessions/week) over a period of 2 weeks.

    Assessment would be done on baseline and after every three sessions.

Study groups in NCT05402540
Study groupRoleWhat they receive
STRAIN COUNTER STRAIN GROUPExperimentalStrain Counter Strain Technique in combination with conventional physiotherapy
Receives: Other: STRAIN COUNTER STRAIN GROUP
ACTIVE RELEASE TECHNIQUE GROUPExperimentalActive Release Technique in combination with conventional physiotherapy
Receives: Other: ACTIVE RELESAE TECHNIQUE GROUP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numerical Rating Scale (NRS):

    In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity [1]. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.

    Measured: 4th week

Secondary outcomes (3)
  1. Range of motion

    A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry.

    Measured: 4th week

  2. Shoulder Pain and Disability Index (SPADI):

    The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.

    To answer the questions, patients place a mark on a 10cm visual analogue scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'. The scores from both dimensions are averaged to derive a total score.

    Measured: 4th week

  3. Manual Muscle Testing (MMT):

    Manual muscle testing (MMT) is a very common practice of orthopedic examination specifically designed to assess function and strength of various muscles, usually when rehabilitating sports injuries or recovering from an illness, MMT grades are usually labelled with the following terms: "zero," "trace," "poor," "fair," "good," and "normal." In addition, manual muscle testing grades can be further described using a numerical scale from 0 through 5.

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start14 Sep 2022
  3. Primary completion2 Apr 2023
  4. Study completion2 Apr 2023

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05402540
Sponsor's protocol ID
REC/01206 Khizar Hayat
Status last verified
Apr 2023
First submitted
21 Apr 2022
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing STRAIN COUNTER STRAIN GROUP and ACTIVE RELESAE TECHNIQUE GROUP in people with Adhesive Capsulitis, 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 5 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 13 Apr 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?

Numerical Rating Scale (NRS): (time frame: 4th week). 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 13 Apr 2023.

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