Injection in Patients With Chronic Shoulder Pain

NCT06135038 | Completed

• 1 other identifier: Physical Medicine+injection
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Shoulder Pain

Keywords

chronic shoulder pain; shoulder injection; suprascapular nerve block; physiotherapy

Outcome Measures

Primary Outcomes (3)

• Visual analogue scale (VAS)-pain

  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 .

  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)

• Shoulder Pain and Disability Index (SPADI)

  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.

  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 Profile (NHP)

  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.

  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)

Study Arms (2)

Suprascapular nerve block with physical therapy

ACTIVE COMPARATOR

Suprascapular Nerve Block was applied to Group I before physical therapy program. After the nerve block, a physical therapy program including standard procedure was applied to the patients in Group 1.

Other: Suprascapular nerve block with physical therapy

Only physical therapy

ACTIVE COMPARATOR

Patients in group 2 were applied only a physical therapy program that included the same standard procedure as group 1.

Other: Group 2 Physical therapy

Interventions

Suprascapular nerve block with physical therapy OTHER

Suprascapular nerve block was applied to the relevant shoulder area of all patients before treatment. Afterwards, a physical therapy program (5 days a week for 3 weeks, a total of 15 sessions) was applied, including 20 minutes of hot pack at 60°C, 20 minutes of conventional TENS at 80 Hz and US at 3 MHz frequency and 1.5 watt/cm2 intensity. After physical therapy, all the participants received therapeutic exercise program (3 sets of 10 reps with 3- minute intervals between the sets) consisting of active-assisted ROM, passive stretching and Codman exercises for their shoulder joint for 30 minutes in accompany with a physiotherapist.

Also known as: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy, Therapeutic Exercise Program

Suprascapular nerve block with physical therapy

Group 2 Physical therapy OTHER

A physical therapy program (5 days a week for 3 weeks, a total of 15 sessions), including a hot pack at 60 ° C for 20 minutes, conventional TENS at 80 Hz for 20 minutes and US at 3 MHz frequency and an intensity of 1.5 watts / cm2, was applied to the relevant shoulder area of all patients. After physical therapy, all the participants received therapeutic exercise program (3 sets of 10 reps with 3- minute intervals between the sets) consisting of active-assisted ROM, passive stretching and Codman exercises for their shoulder joint for 30 minutes in accompany with a physiotherapist.

Also known as: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy, Therapeutic Exercise Program

Only physical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

UsakU

Merkez, Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Physical Therapy Modalities; Transcutaneous Electric Nerve Stimulation; Therapeutics

Intervention Hierarchy (Ancestors)

Rehabilitation; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Officials

• Kağan Özkuk

  Uşak University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 18, 2023
• Study Start: February 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)