Chronic Shoulder PainNCT06135038
Injection in Patients With Chronic Shoulder Pain
A study testing Suprascapular nerve block with physical therapy and Group 2 Physical therapy in people with Chronic Shoulder Pain, run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- Suprascapular nerve block with physical therapy and Group 2 Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Shoulder Injection in Patients With Chronic Shoulder Pain Contribute to Physiotherapy?
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.
Read more
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.
Read the 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).
- Conditions
- Chronic Shoulder Pain
- Being tested
- Suprascapular nerve block with physical therapy, Group 2 Physical therapy
- Keywords
- chronic shoulder pain, shoulder injection, suprascapular nerve block, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular nerve block with physical therapyOther
Also called Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy, Therapeutic Exercise Program
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.
Group 2 Physical therapyOther
Also called Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy, Therapeutic Exercise Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Group 2 Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Feb 2020
- Primary completion1 May 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kagan Ozkuk, Uşak University
- Investigators
- Kağan Özkuk, Study director, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135038
- Sponsor's protocol ID
- Physical Medicine+injection
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Shoulder Injection in Patients With Chronic Shoulder Pain Contribute to Physiotherapy?
- ClinicalTrials.gov ID
- NCT06135038
- Acronym / sponsor ID
- Physical Medicine+injection
- Conditions
- Chronic Shoulder Pain
- Keywords
- chronic shoulder pain, shoulder injection, suprascapular nerve block, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprascapular nerve block with physical therapy | Active comparator | Other: Suprascapular nerve block with physical therapySuprascapular 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. |
| Only physical therapy | Active comparator | Other: Group 2 Physical therapyPatients in group 2 were applied only a physical therapy program that included the same standard procedure as group 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprascapular nerve block with physical therapyAlso: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy, Therapeutic Exercise ProgramSuprascapular 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. | Other | Suprascapular nerve block with physical therapy |
| Group 2 Physical therapyAlso: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy, Therapeutic Exercise ProgramA 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. | Other | Only physical therapy |
Primary outcome
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 .
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kağan Özkuk study director
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprascapular nerve block with physical therapy and Group 2 Physical therapy in people with Chronic Shoulder Pain, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.