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NCT Number: NCT05649410

Effects of Sleeper Stretch and Mobilizations With Movement in Patients With Adhesive Capsulitis

Adhesive capsulitis is a condition characterized by progressive declination range of motion at the glenohumeral joint due to tightness of capsule. The joint capsule and its surrounding connective tissue becomes stiffed, inflamed and shortened which in return causes decrease in range of motion that progress to chronic pain and stiffness. Adhesive capsulitis is a self-limiting disorder that resolves within 1-3 years.

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Physiotherapy clinic Saidpur Road

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

Idiopathic (primary) adhesive capsulitis occurs spontaneously without a specific precipitating event. Primary adhesive capsulitis results from a chronic inflammatory response with fibro elastic proliferation, which may actually be an abnormal response from the immune system. Secondary adhesive capsulitis occurs after a shoulder injury or surgery or may be associated with another condition such as diabetes, rotator cuff injury, cerebrovascular accident or cardiovascular disease, which may prolong recovery and limit outcomes The prevalence of adhesive capsulitis is estimated at 2% to 5% of the general population. Frozen shoulder mainly affects individuals of 40-65 years of age with a female predominance. Adhesive Capsulitis follows a capsular pattern where external rotation is greatly restricted followed by abduction and internal rotation. Adhesive capsulitis is classically characterized by three stages. The length of each stage is variable, but typically the first stage (freezing) lasts for 3 to 6 months, the second stage (frozen) from 3 to 18 months and the final stage (thawing) from 3 to 6 months Currently various techniques are used, such as the application of moist heat, strengthening exercises, stretching and manual exercises for the treatment of Adhesive Capsulitis .Manual therapy techniques such as high and low grade glenohumeral mobilizations ,Proprioceptive neuromuscular facilitation techniques, Muscle energy Techniques, Mobilization with movement, and Sleeper stretch all have been proved effective for the treatment of adhesive capsulitis through different researches. Conservative treatment includes various exercises method and physical therapy modalities such as a heat therapy, transcutaneous electrical nerve stimulation (TENS), Ultrasound (US), Acupuncture and (Light Amplification by Stimulated Emission of Radiation) LASER

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Adhesive Capsulitis of stage 1 and 2.
  • Patients with idiopathic adhesive capsulitis.
  • Patients with unilateral involvement having painful stiff shoulder for 3 or more months without any shoulder trauma.
  • Marked loss in active and passive Range of Motion (Abduction, external and internal rotation) minimum 50% compared to the unaffected side.
  • 1.5cm asymmetry on bilateral comparison during lateral scapular slide test.

Exclusion criteria

  • Patients with shoulder pain due to neurological abnormalities e.g. Hemiplegia.
  • Patients with Rotator cuff injury or tear.
  • Recent trauma to upper limb.
  • Disorders of bones such as fractures, osteoporosis, glenohumeral arthritis.
  • Cervical spondylosis or cervical radiculopathy.
  • Any malignancy or tumor.
  • Patients having any intra articular injection in the gleno-humeral joint during last three months.
  • Patients with cardiovascular impairments

Treatment and study plan

mobilization with movement and conventional therapy

Other

Mobilization with movement for Flexion, Abduction, Internal rotation, external rotation

sleeper stretch along with conventional therapy

Other

it will be performed with the patient in side lying on the affected side to stabilize the scapula against the table and both the shoulder and elbow flexed to 90°.In this position, passive Internal Rotation is applied to the affected shoulder by the therapist or patients opposite hand.

Primary outcomes

  1. NPRS (Numeric Pain Rating Scale)

    Time frame: four weeks

    The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable. intraclass correlation coefficient = 0.74 for shoulder pain.

  2. Goniometer

    Time frame: four weeks

    Shoulder range of motion i.e. Shoulder Flexion, Extension, Abduction, Adduction, Internal rotation, External rotation will be measured using goniometer, intraclass correlation coefficient for using goniometer for shoulder joint Range Of Motion ranges from 0.91 to 0.99

  3. SPADI (Shoulder Pain and Disability Index)

    Time frame: four weeks

    The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with Activities of Daily Livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The patient is instructed to choose the number that best describes their level of pain and extent of difficulty using the involved shoulder. The pain scale is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is expressed as a percentage. A score of 0 indicates best 100 indicates worst. A higher score shows more disability. SPADI is reliable for subjects with Adhesive capsulitis, intraclass correlation coefficient for pain scale=0.989 and intraclass correlation coefficient for disability=0.990

  4. Scapulohumeral Rhythm

    Time frame: four weeks

    Scapular upward rotation will be measured using inclinometer placed at the spine of scapula. Patient will be advised to perform shoulder abduction and measurements will be taken at 3 degrees i.e. 0 to 45degree, 0 to 90 degree, 0 to 120 degree. 3 measurements will be taken at each range and then their mean will be calculated. Scapulohumeral rhythm will be measured by dividing humeral elevation with scapular upward rotation. Scapulohumeral rhythm=humeral elevation/scapular upward rotation. The intraclass correlation coefficient for measuring Scapulohumeral rhythm using inclinometer is > 0.892.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Sleeper Stretch and Mobilization With Movement in Patients With Adhesive Capsulitis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2022
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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