Clinical trial NCT06135038: Injection in Patients With Chronic Shoulder Pain
Official title: Does Shoulder Injection in Patients With Chronic Shoulder Pain Contribute to Physiotherapy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Shoulder Pain
Keywords: chronic shoulder pain
shoulder injection
suprascapular nerve block
physiotherapy
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

METHODS The study was designed as a prospective, randomized, controlled, and single-blind study. A total of 110 patients who were admitted to the physical therapy and rehabilitation outpatient clinic with pain and movement restriction in their shoulder and who signed the patient information consent form were included in the study.

A total of 110 patients who met the inclusion criteria of the study were divided into 2 groups (55 patients in each group) with simple randomization method by using a table of random numbers created on the computer. The researchers who made the assessment measurements were unaware of which patient was in which group. Statistical analysis of the results was performed by a biostatistician who had no information about the therapies the patient groups received.

All the patients included in the study received a total of 15 sessions of physical therapy program 5 times a week for 3 weeks. All the patients received hot pack at 60°C for 20 minutes and conventional TENS at 80 Hz for 20 minutes and US at 3 megahertz frequency, and 1.5watt/cm2 intensity for their involved shoulder. 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 range of motion (ROM), passive stretching and Codman exercises for their shoulder joint for 30 minutes in accompany with a physiotherapist. Suprascapular Nerve Block was applied to Group I before treatment. The patients were assessed with the measurements of visual analogue scale (VAS)-pain, Shoulder Pain and Disability Index (SPADI) and The Nottingham Health Profile (NHP) before and immediately after the intervention and at 12 weeks after the end of the intervention (approximately week 15).

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale (VAS)-pain
timeFrame: 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)
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 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)
measure: The Nottingham Health Profile (NHP)
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: UsakU
state: Uşak
Study officials:
affiliation: Uşak University
name: Kağan Özkuk
role: STUDY_DIRECTOR
References: