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NCT Number: NCT04578366

Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis

Adhesive capsulitis refers to the occurrence of pain and a gradual decline in the range of motion (ROM) due to slow increases in synovial hypertrophy and the adhesion between the synovial membrane and articular surface. It leads to the loss of flexibility and difficulties with the activities of daily living (ADLs) due to chronic inflammation accompanied by intra-articular fibrosis. The real cause of this syndrome is unknown but there are some predisposing factors involved such as synovial cell hyperplasia, fibrosis of the capsule due to cytokines or other inflammatory factors. In the current study investigator will compare the effects of Extracorporeal Shockwave Therapy (ESWT) along with conventional therapy to treat the adhesive capsulitis.

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Key information

Conditions

Adhesive Capsulitis of Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah IU

Lahore, 54000, Pakistan

About this study

This study will be a Randomized Controlled Trail conducted at Horizon hospital, Lahore. The study will be completed within the time duration of Six months. Consecutive sampling technique will be used to collect the data. The sample size of 44 patients will be taken in this study to find the effects of ESWT on pain, ROM, functional mobility. Patient will be divided into two groups. Group A will be treated with ESWT with conventional therapy and Group B will be treated with conventional therapy. Constant Shoulder Score (CSS) and the Oxford Shoulder Score (OSS) tools will be used to measure the outcomes of the study.

One session of treatment per week for four weeks will be given. Pretest, posttest at 4th week and followup of 24th weeks will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Relapsed or episode of pain score ≥5 at assessment with a past history of pain for at least 2 months.
  • ROM restriction (>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)
  • No treatment other than analgesics with unresponsive ROM restriction for the past 2months.
  • Unwilling or waiting and did not undergo joint injection.

Exclusion criteria

  • bilateral shoulder involvement
  • History of previous surgery on the shoulder
  • Shoulder fracture
  • Cancer
  • Glenohumeral or Acromioclavicular arthritis
  • Inflammatory disorders
  • Bleeding disorders
  • Diabetes mellitus
  • Presence of severe osteoporosis
  • Pulmonary diseases
  • Any neuromuscular disorders
  • Pregnancy
  • Implanted pacemaker

Treatment and study plan

Extracorporeal shockwave therapy

Device

ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

Other names: Experimental Group

conventional treatment

Other

hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder

Primary outcomes

  1. Constant Shoulder Score (CSS)

    Time frame: 8 months

    The functional outcome of shoulder. Grading the Constant Shoulder Score (Difference between normal and Abnormal Side)

    >30 Poor 21-30 Fair 11-20 Good <11 Excellent

  2. Range of motion

    Time frame: 8 months

    Oxford Shoulder Score (OSS), increasing score shows improvement, decrease in scores shows deterioration.

Secondary outcomes

  1. NPRS-numeric pain rating scale

    Time frame: 8 months

    This scale ranges 0-10, 10 means severe pain while 0 means no pain

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects Of Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2020
Registry last updated
Oct 8, 2020

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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