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Clinical Trials/NCT06135038
NCT06135038CompletedNot Applicable

Does Shoulder Injection in Patients With Chronic Shoulder Pain Contribute to Physiotherapy?

Uşak University2 sites in 1 country110 target enrollmentStarted: February 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
110
Locations
2
Primary Endpoint
Shoulder Pain and Disability Index (SPADI)

Study Overview

Brief Summary

Background: Chronic shoulder pain (CSP) is a musculoskeletal disease characterized by pain lasting more than 3 months.

Purpose: This study aimed to determine whether pre-treatment injection in CSP treatment contributes to pain, functionality and quality of life.

Methods: A total of 110 patients who met the inclusion criteria of the study were divided into 2 groups (55 patients in each group).

A standard 15-session physical therapy program (hot pack, transcutaneous electric nerve stimulation(TENS), US and therapeutic exercises) was applied to all patients in both groups. Suprascapular Nerve Block was applied to Group I before treatment.

Assessments were made using VAS-Pain, Shoulder Pain and Disability Index (SPADI) and The Nottingham Health Profile (NHP) before and at the end of the treatment and in the posttreatment 3th months.

Detailed Description

INTRODUCTION Chronic pain is a common condition, affecting 20% of people worldwide and accounting for 15% to 20% of doctor visits. One of the most common causes of chronic pain and disability in the world is musculoskeletal system diseases. Pain and limitations in daily living activities and psychological problems that develop due to pain negatively affect the quality of life of patients.

Shoulder pain is the third most common musculoskeletal system disease that causes pain and loss of function. Shoulder pain is characterized by chronicity and high recurrence rates due to its anatomy and joint structure.

Chronic and frequently recurring shoulder pain can cause loss of function and not only affects the individual's entire life, but also becomes a socio-economic problem with the financial burden it brings.

There are many pharmacological or non-pharmacological treatment approaches in the treatment of pain. Many physical therapy methods are used in combination for chronic shoulder pain (e.g. Hotpack, TENS, ultrasound, exercise, etc.). Alternative treatments and their combinations are gaining importance today in painful shoulder problems that are difficult to treat with physiotherapy due to their anatomical and functional structure.

This study aimed to determine whether pre-treatment injection in CSP treatment contributes to pain, functionality and quality of life.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Between the ages of 18-65,
  • Having pain lasting longer than 3 months,
  • Full range of joint motion
  • Patients with shoulder pain due to biceps tendinitis, impingement syndrome, rotator cuff diseases (tendinosis, calcific tendonitis, etc.)

Exclusion Criteria

  • Inflammatory rheumatic disease (rheumatoid arthritis, ankylosing spondylitis, etc.),
  • Full thickness rotator cuff tear
  • Glenohumeral disorders (arthritis, osteoarthritis, osteonecrosis, glenohumeral instability)
  • Regional disorders (cervical radiculopathy, brachial neuritis, entrapment neuropathies, reflex sympathetic dystrophy, neoplasms, etc.)
  • Diagnosed with metabolic syndrome, diabetes mellitus (DM), hypertension (HT)
  • Having a diagnosed neuro-psychiatric problem,
  • Undergoing malignancy treatment,
  • Having a bleeding disease,
  • Having an infectious disease with fever,
  • Who have undergone surgery on the shoulder,
  • Patients who received physical therapy in the last year

Outcomes

Primary Outcomes

Shoulder Pain and Disability Index (SPADI)

Time Frame: Outcome measure evaluated; 1. Before the intervention, 2. Immediately after the intervention, 3. At 12 weeks after the end of the intervention (approximately week 15)

The shoulder Pain and Disability Index was developed to evaluate pain and disability . It consists of 2 subscales, consisting of a total of 13 items (5 items for pain, 8 items for disability) numerically rated from 0 to 10. The total score ranges from 0 to 100. Higher scores represent increased pain and impaired shoulder function.

Visual analogue scale (VAS)-pain

Time Frame: Outcome measure evaluated; 1. Before the intervention, 2. Immediately after the intervention, 3. At 12 weeks after the end of the intervention (approximately week 15)

Visual analogue scale (VAS) is one of the frequent methods used in the identification of the severity of pain. It is formed by 100 mm vertical and horizontal lines. The distance between the lowest VAS score and the mark of the patient was measured as mm (0-100) and the numerical value of the pain severity was determined .

The Nottingham Health Profile (NHP)

Time Frame: Outcome measure evaluated; 1. Before the intervention 2. Immediately after the intervention, 3. At 12 weeks after the end of the intervention (approximately week 15)

The Nottingham Health Profileis a general quality of life questionnaire measuring self-perceived health problems and the effects of these problems on normal daily activities. The questionnaire consists of 38 questions and six domains. For each domain, "0" represents the best state of health and "100" the worst state of health.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Uşak University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kagan Ozkuk

Assoc. Prof.

Uşak University

Study Sites (2)

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