Cervical RadiculopathyNCT04597112
Effect of Myofascial Release Technique in Patients with Unilateral Cervical Radiculopathy
A study testing Myofascial Release Technique and Exercise in people with Cervical Radiculopathy and Cervical Radicular Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effectiveness of myofascial release technique on pain, range of motion, muscle strength, functionality and quality of life in individuals diagnosed with cervical radiculopathy with unilateral arm involvement and compare this with exercise. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Cervical Radiculopathy, Cervical Radicular Pain, Cervical; Hernia
- What is being tested?
- Myofascial Release Technique and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2020to 1 Jun 2021
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Getting a diagnosis of cervical radiculopathy
- Unilateral upper extremity symptoms at least for a month
- The diagnosis is confirmed by the medical board report
- Being between the ages of 30-65
- Voluntary acceptance to participate in the study
Who cannot join
- Previous cervical surgery
- Previous cervical trauma
- Have had myofascial therapy or conventional therapy for cervical radiculopathy
- Long-term use of corticosteroids
- Congenital torticollis history
- Using nonsteroidal anti-inflammatory drugs for long time
Show all 11Show fewer
- Migraine
- Cancer
- Tumor
- Osteoporosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the effectiveness of myofascial release technique on pain, range of motion, muscle strength, functionality and quality of life in individuals diagnosed with cervical radiculopathy with unilateral arm involvement and compare this with exercise. The individuals included in the study will be randomized into two groups, 17 control and 17 study groups. Sessions will be 3 days a week for 4 weeks. Conventional physiotherapy and exercise program will be applied to the control group, conventional physiotherapy and myofascial release technique will be applied in the intervention group. Conventional physiotherapy methods; It will include Transcutaneous Electrical Nerve Stimulation (TENS), Ultrasound (US), hotpack agents. Exercise program; extension, right and left lateral flexion, right and left rotation exercises, chin-tuck, right and left upper trapezius muscle group stretching, neck extensor muscle group isometric strengthening exercises. Myofascial release will be applied to the fingers, wrist flexor-extensor muscle groups, elbow flexor-extensor muscle groups, pectoral muscles and rotator cuff muscle groups. Patients will be evaluated before and after treatment with Visual Analogue Scale (VAS), Goniometric measurements, algometer, myometer, Neck Disability Scale, "Disability of Arm, Shoulder and Hand" Questionnaire (DASH).
- Conditions
- Cervical Radiculopathy, Cervical Radicular Pain, Cervical; Hernia, Cervical Disc Disease, Cervical Disc Herniation, Pain
- Being tested
- Myofascial Release Technique, Exercise
- Keywords
- Cervical Radiculopathy, Pain, Radiculopathy, Cervical, Hernia, Myofascial Release, Exercise
- Medical subject headings
- Radiculopathy, Hernia, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Release TechniqueOther
Myofascial release focuses on reducing pain by easing the tension and tightness in the trigger points. Therapist will gently massage the myofascia and feel for stiff or tightened areas. Normal myofascia should feel pliable and elastic. The therapist will begin massaging and stretching the areas that feel rigid with light manual pressure. The therapist then aids the tissue and supportive sheath in releasing pressure and tightness. The process is repeated multiple times on the same trigger point and on other trigger points until the therapist feels the tension is fully released.
ExerciseOther
Exercise is recommended by physical therapists for most cervical radiculopathy patients.
In this study, a customized exercise program will be applied for patients with cervical radiculopathy.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Release Group | Experimental | Intervention group, who received conventional therapy and myofascial release therapy.All participants will be given conventional treatment 3 days a week for 4 weeks. Conventional treatment will include 20 minutes hotpack, 5 minutes ultrasound, 20 minutes Transcutaneous Electrical Stimulation. In the intervention group, the myofascial release technique will be applied to the wrist flexors and extensors, elbow flexors and extensors, pectoralis, supraspinatus, infraspinatus, trapezius muscles, starting from the fingers after the conventional treatment, 3 days a week for 4 weeks. Receives: Other: Myofascial Release Technique |
| Exercise Group | Active comparator | The control group will consist of patients who received conventional therapy and exercise therapy. All participants will be given conventional treatment 3 days a week for 4 weeks. Conventional treatment will include 20 minutes hotpack, 5 minutes ultrasound, 20 minutes Transcutaneous Electrical Stimulation. After conventional treatment, a program consisting of neck extension, lateral flexion and rotation range of motion, stretching of the trapezius muscles and strengthening of the neck extensor muscles will be applied to the control group in the presence of a physiotherapist 3 days a week for 4 weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algometer
It is a device used to evaluate the sensitivity to pain and to determine the perception of pressure. The pressure algometer has proven useful in evaluating fibrositis and hypersensitive spots, trigger points, arthritis activation, and visceral pain-pressure sensitivity.
Measured: 10 minutes
Myometer
Hand myometer is a means of expressing force quantitatively. It is preferred over other dynamometers because of its ease of use and portability.
Measured: 10 minutes
Electrogoniometer
It is an evaluation tool used to record the objective measurement of joint range of motion.
Measured: 10 minutes
Visual Analog Scale
Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his / her condition is appropriate by drawing a line or by placing a dot or marking.
Measured: 1 minutes
Secondary outcomes (2)
Neck Disability Index
It is a test consisting of ten parts that determines to what extent neck pain affects daily life activities. The questions are of a nature that includes the intensity of pain and the effect of pain on occupational and social activity and its relationship with emotional factors. 10 cm visual analogue scale (VAS) is used for each question. High scores indicate the severity of the disease.
Measured: 10 minutes
Disability of Arm Shoulder and Hand Test
This questionnaire evaluates the disability and activity limitations resulting from upper extremity injury, as well as the restriction of leisure activities and work participation. The DASH questionnaire consists of three parts. According to the survey results; A result of 0-100 is obtained from each section. (0 = no apology, 100 = maximum apology).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start13 Oct 2020
- Primary completion10 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatih bali, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597112
- Sponsor's protocol ID
- 10840098-604.01.01-E.1062
- Status last verified
- Nov 2024
- First submitted
- 15 Oct 2020
- Last updated
- 15 Nov 2024
- 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 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofascial Release Technique in Patients with Unilateral Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT04597112
- Acronym / sponsor ID
- 10840098-604.01.01-E.1062
- Conditions
- Cervical Radiculopathy, Cervical Radicular Pain, Cervical; Hernia, Cervical Disc Disease, Cervical Disc Herniation, Pain
- Keywords
- Cervical Radiculopathy, Pain, Radiculopathy, Cervical, Hernia, Myofascial Release, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 22 Oct 2020 (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.
The aim of the study is to investigate the effectiveness of myofascial release technique on pain, range of motion, muscle strength, functionality and quality of life in individuals diagnosed with cervical radiculopathy with unilateral arm involvement and compare this with exercise. The individuals included in the study will be randomized into two groups, 17 control and 17 study groups. Sessions will be 3 days a week for 4 weeks. Conventional physiotherapy and exercise program will be applied to the control group, conventional physiotherapy and myofascial release technique will be applied in the intervention group. Conventional physiotherapy methods; It will include Transcutaneous Electrical Nerve Stimulation (TENS), Ultrasound (US), hotpack agents. Exercise program; extension, right and left lateral flexion, right and left rotation exercises, chin-tuck, right and left upper trapezius muscle group stretching, neck extensor muscle group isometric strengthening exercises. Myofascial release will be applied to the fingers, wrist flexor-extensor muscle groups, elbow flexor-extensor muscle groups, pectoral muscles and rotator cuff muscle groups. Patients will be evaluated before and after treatment with Visual Analogue Scale (VAS), Goniometric measurements, algometer, myometer, Neck Disability Scale, "Disability of Arm, Shoulder and Hand" Questionnaire (DASH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release Group | Experimental | Other: Myofascial Release TechniqueIntervention group, who received conventional therapy and myofascial release therapy.All participants will be given conventional treatment 3 days a week for 4 weeks. Conventional treatment will include 20 minutes hotpack, 5 minutes ultrasound, 20 minutes Transcutaneous Electrical Stimulation. In the intervention group, the myofascial release technique will be applied to the wrist flexors and extensors, elbow flexors and extensors, pectoralis, supraspinatus, infraspinatus, trapezius muscles, starting from the fingers after the conventional treatment, 3 days a week for 4 weeks. |
| Exercise Group | Active comparator | Other: ExerciseThe control group will consist of patients who received conventional therapy and exercise therapy. All participants will be given conventional treatment 3 days a week for 4 weeks. Conventional treatment will include 20 minutes hotpack, 5 minutes ultrasound, 20 minutes Transcutaneous Electrical Stimulation. After conventional treatment, a program consisting of neck extension, lateral flexion and rotation range of motion, stretching of the trapezius muscles and strengthening of the neck extensor muscles will be applied to the control group in the presence of a physiotherapist 3 days a week for 4 weeks. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Getting a diagnosis of cervical radiculopathy
- Unilateral upper extremity symptoms at least for a month
- The diagnosis is confirmed by the medical board report
- Being between the ages of 30-65
- Voluntary acceptance to participate in the study
Key exclusion criteria (11 listed)
- Previous cervical surgery
- Previous cervical trauma
- Have had myofascial therapy or conventional therapy for cervical radiculopathy
- Long-term use of corticosteroids
- Congenital torticollis history
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 |
|---|---|---|
| Myofascial Release TechniqueMyofascial release focuses on reducing pain by easing the tension and tightness in the trigger points. Therapist will gently massage the myofascia and feel for stiff or tightened areas. Normal myofascia should feel pliable and elastic. The therapist will begin massaging and stretching the areas that feel rigid with light manual pressure. The therapist then aids the tissue and supportive sheath in releasing pressure and tightness. The process is repeated multiple times on the same trigger point and on other trigger points until the therapist feels the tension is fully released. | Other | Myofascial Release Group |
| ExerciseExercise is recommended by physical therapists for most cervical radiculopathy patients. In this study, a customized exercise program will be applied for patients with cervical radiculopathy. | Other | Exercise Group |
Primary outcome
Algometer
Time frame: 10 minutes
It is a device used to evaluate the sensitivity to pain and to determine the perception of pressure. The pressure algometer has proven useful in evaluating fibrositis and hypersensitive spots, trigger points, arthritis activation, and visceral pain-pressure sensitivity.
Myometer
Time frame: 10 minutes
Hand myometer is a means of expressing force quantitatively. It is preferred over other dynamometers because of its ease of use and portability.
Electrogoniometer
Time frame: 10 minutes
It is an evaluation tool used to record the objective measurement of joint range of motion.
Visual Analog Scale
Time frame: 1 minutes
Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his / her condition is appropriate by drawing a line or by placing a dot or marking.
2 secondary outcomes
Neck Disability Index
Time frame: 10 minutes
Disability of Arm Shoulder and Hand Test
Time frame: 10 minutes
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 15 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release Technique and Exercise in people with Cervical Radiculopathy and Cervical Radicular Pain, run by Istanbul Medipol University Hospital 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 5 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 15 Nov 2024. 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?
Algometer (time frame: 10 minutes). The study lists 4 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 15 Nov 2024.