Nonspecific Neck PainMETSS-NPNCT06199063
Muscle Energy Techniques and Self-Stretching in Nonspecific Neck Pain
A study testing Self-Streching Exercises, Post-Isometric Relaxation Exercises and Reciprocal-Inhibiton Exercises in people with Nonspecific Neck Pain and Exercise, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
Non-specific neck pain (NSNP) is defined as pain not associated with neurological and specific pathologies in the posterior and lateral part of the neck between the superior nuchal line and the first thoracic vertebra. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonspecific Neck Pain, Exercise
- What is being tested?
- Self-Streching Exercises, Post-Isometric Relaxation Exercises and Reciprocal-Inhibiton Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2023to 4 Jul 2023
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Being a volunteer to participate into the study
- Not having diagnosed orthopedic and neurological problems
- Having Neck pain for at least four months
Who cannot join
- Having diagnosed with active infectious pathology
- Having cervical spine fracture/previous cervical or thoracic surgery
- Having a history of severe trauma to the cervical spine
- Having a history of malignant tumors
- Having diagnosed with structural deformity
- Being used of a medical orthopaedic prosthesis
- Having a pacemaker
- Having diagnosed with disc prolapse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Muscle Energy Techniques and Self-Stretching in Individuals With Nonspecific Neck Pain
Non-specific neck pain (NSNP) is defined as pain not associated with neurological and specific pathologies in the posterior and lateral part of the neck between the superior nuchal line and the first thoracic vertebra. Many conservative treatment modalities including different exercise techniques are used in the treatment of NSNP. Therefore, the aim of our study was to investigate the effect of these techniques.
Read the detailed description
Non-specific neck pain (NSNP) is defined as pain not associated with neurological and specific pathologies (infection, fracture, inflammation, etc.) in the posterior and lateral part of the neck between the superior nuchal line and the first thoracic vertebra. Neglecting this pain can lead to muscle spasms, stiffness, and many other serious complications. Most neck pain is caused by trigger points in the cervicothoracic muscles. Trigger points cause the muscles to weaken, and neck pain with weak cervical muscles has a negative impact on a person's quality of life.
The estimated incidence of neck pain ranges from 10.4% to 21.3% each year and is affecting an increasing number of computer and office workers. Pain intensity is low in most new cases, but disabling neck pain develops in 0.6% of the population. Therefore, it is important to investigate which treatment modality is more effective in reducing neck pain and its symptoms. Some recent studies report evidence in favor of a particular type of exercise, while others report that there is no superior type or dose of exercise.
Neck pain recurs and develops within one to five years in 20% of patients and the rate of complete recovery in these cases is very low. Neck pain is the most frequently investigated musculoskeletal problem after low back pain. It is defined as non-specific neck pain due to multifactorial etiology. Many conservative treatment modalities are used in the treatment of NSNP. These include clinical exercises, medical treatments, neural therapy, manual therapy methods, massage, acupuncture, and various physical therapy modalities. Muscle energy techniques (MET) are manual therapy methods that involve soft tissue manipulation using precise and controlled, patient-initiated, isometric, and/or isotonic contractions to improve musculoskeletal function and reduce pain. MET can be used to mobilize a joint with a limited range of motion, lengthen a spastic or shortened muscle, reduce local edema, and strengthen a physiologically weak muscle or muscle group.
Post-isometric relaxation (PIR) is defined as a reduction in the tone of the agonist muscle after an isometric contraction. This technique aims to reduce muscle tension by regulating muscle function and is used to mobilize the restricted joint, reduce edema, and lengthen and strengthen muscles in both subacute and chronic conditions. Studies have also used PIR for neck pain.
The muscle spindle is one of the sensory receptors in skeletal muscle. Its function is to provide proprioceptive information to the cerebral cortex. As the muscle lengthens, the muscle spindle is activated, and a reflex contraction of the agonist muscle and relaxation of the antagonist muscle occurs. This process is known as reciprocal inhibition (RI). Studies using the RI technique in people with neck pain were found. However, no studies were found in people with non-specific neck pain.
Stretching is a general term describing a therapeutic maneuver used to increase the extensibility of soft tissues. Self-stretching (SS) is the self-application of this technique. Studies comparing the effects of MET with different treatment modalities in people with non-specific neck pain were identified in the literature. These trials found similar effects and varying degrees of superiority in reducing pain intensity and increasing range of motion (ROM). In the literature, studies have compared stretching with MET in people with neck pain or compared MET with different treatment methods and examined their effects on variables such as pain and ROM. However, no study was found that compared different METs and self-training in individuals with NSNP and investigated the immediate effect of EMG. Therefore, the aim of our study was to investigate the effect of these techniques. It was thought that the information obtained as a result of the study would guide the creation and development of rehabilitation programs.
The hypotheses of the study are as follows:
Hypothesis 1: The PIR technique applied to individuals with NSNP has a positive effect on pain intensity, pressure pain threshold, range of motion, and muscle activation.
Hypothesis 2: The RI technique applied to individuals with NSNP has a positive effect on pain intensity, pressure pain threshold, range of motion, and muscle activation.
Hypothesis 3: SS technique applied to individuals with NSNP has a positive effect on pain intensity, pressure pain threshold, range of motion, and muscle activation.
Hypothesis 4: Muscle energy techniques applied to individuals with NSNP have more positive effects on pain intensity, pressure pain threshold, range of motion and muscle activation than SS technique.
- Conditions
- Nonspecific Neck Pain, Exercise
- Being tested
- Self-Streching Exercises, Post-Isometric Relaxation Exercises, Reciprocal-Inhibiton Exercises
- Keywords
- Neck Pain, Muscle Stretching Exercise, Electromyography, Range of Motion, Pain Threshold
- Medical subject headings
- Motor Activity, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Streching ExercisesOther
Also called SSE
The participants in the SSE group; received 1 session SSE with 10 repetitions, about 30 min. The assessments were applied before and after the session.
Post-Isometric Relaxation ExercisesOther
Also called PIRE
The participants in the PIRE group; received 1 session PIRE with 10 repetitions, about 30 min. The assessments were applied before and after the session.
Reciprocal-Inhibiton ExercisesOther
Also called RIE
The participants in the RIE group; received 1 session RIE with 10 repetitions, about 30 min. The assessments were applied before and after the session.
| Study group | Role | What they receive |
|---|---|---|
| Self-Stretching Exercises Group (SSEG) | Experimental | Self-stretching (SS) is defined as stretching applied by the individual to himself/herself. For this application, firstly the painful area was determined, and stretching was applied to the muscle with pain. Firstly, the participant stood with his/her arm free on the side to be stretched and lateral flexed his/her head. With his/her other hand, he/she applied 10 seconds of stretching in the direction of lateral flexion, a 10-second rest period was given between each stretching, and this method was performed with a total of 10 repetitions. Receives: Other: Self-Streching Exercises |
| Post-Isometric Relaxation Exercises Group (PIREG) | Experimental | Post-isometric relaxation (PIR) was performed by a physiotherapist in a supine position. The physiotherapist sat on the head side of the patient. The painful side was determined, and the physiotherapist fixed the head with his/her hand and performed 50% voluntary isometric contraction of the painful muscle for 10 seconds. Then, the physiotherapist asked the patient to relax and stretch for 10 seconds to lateral flexion. This method was 10 repetitions with 10 seconds of rest between each repetition. Receives: Other: Post-Isometric Relaxation Exercises |
| Reciprocal-Inhibition Exercises Group (RIEG) | Experimental | Reciprocal inhibition (RI) was applied by a physiotherapist in a supine position. The physiotherapist sat on the head side of the patient. The painful side was determined, and the physiotherapist fixed the head with his/her hand and performed 50% voluntary isometric contraction of the antagonist of the painful muscle for 10 seconds. Then physiotherapist asked the patient to relax and stretch for 10 seconds in the lateral flexion direction. This method was 10 repetitions and there were 10 seconds of rest between each repetition. Receives: Other: Reciprocal-Inhibiton Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain Severity
Pain severity was assessed using the Visual Analogue Scale (VAS). The VAS is a subjective pain scale in which the intensity of pain is rated 0-10 cm on a horizontal line. "0" refers to "no pain, while "10" refers to worst pain.
Measured: Before and up to 4 weeks
Assessment of Pressure Pain Threshold
The Wagner digital algometer (Wagner Instruments) was used to measure the pressure pain threshold (PPT). Trigger points in the upper trapezius and cervical paravertebral muscles were palpated and the most painful trigger points were marked as four separate points on the right and left. The algometer was placed perpendicular to the trigger points and the pressure was increased until the first moment when the patient felt pain and the probe was withdrawn with the expression "I felt it/OK". At this point, the PPT value in Newton read from the algometer was recorded in three repetitions.
Measured: Before and up to 4 weeks
Assessment of Range of Motion
The subjects' neck ROMs were recorded in degrees by measuring the degrees of flexion, extension, lateral flexion and rotation three times with a manual goniometer while sitting upright in a chair.
Measured: Before and up to 4 weeks
Assessment of Muscle Activation
Muscle activation was assessed with a MegaWin WBA eight-channel EMG device. Superficial EMG electrodes were placed on the upper trapezius and sternocleidomastoid muscles, right and left. A total of 4 outputs were used, 2 muscles on each side. Myoelectric signals were obtained, and muscular contraction and inhibition were assessed. Additionally, the "IC/MVIC" percentage was calculated to determine the workload on the muscle during the activity.
Measured: Before and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start4 Feb 2023
- Primary completion14 Apr 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonspecific Neck 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferruh Taşpınar, Izmir Democracy University
- Investigators
- Betul Taspinar, Prof. Dr., Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199063
- Sponsor's protocol ID
- NeckPain-METSS-35
- Acronym
- METSS-NP
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 10 Jan 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Muscle Energy Techniques and Self-Stretching in Individuals With Nonspecific Neck Pain
- ClinicalTrials.gov ID
- NCT06199063
- Acronym / sponsor ID
- METSS-NP / NeckPain-METSS-35
- Conditions
- Nonspecific Neck Pain, Exercise
- Keywords
- Neck Pain, Muscle Stretching Exercise, Electromyography, Range of Motion, Pain Threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 4 Feb 2023 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 10 Jan 2024 (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.
Non-specific neck pain (NSNP) is defined as pain not associated with neurological and specific pathologies in the posterior and lateral part of the neck between the superior nuchal line and the first thoracic vertebra. Many conservative treatment modalities including different exercise techniques are used in the treatment of NSNP. Therefore, the aim of our study was to investigate the effect of these techniques.
Detailed description
Non-specific neck pain (NSNP) is defined as pain not associated with neurological and specific pathologies (infection, fracture, inflammation, etc.) in the posterior and lateral part of the neck between the superior nuchal line and the first thoracic vertebra. Neglecting this pain can lead to muscle spasms, stiffness, and many other serious complications. Most neck pain is caused by trigger points in the cervicothoracic muscles. Trigger points cause the muscles to weaken, and neck pain with weak cervical muscles has a negative impact on a person's quality of life.
The estimated incidence of neck pain ranges from 10.4% to 21.3% each year and is affecting an increasing number of computer and office workers. Pain intensity is low in most new cases, but disabling neck pain develops in 0.6% of the population. Therefore, it is important to investigate which treatment modality is more effective in reducing neck pain and its symptoms. Some recent studies report evidence in favor of a particular type of exercise, while others report that there is no superior type or dose of exercise.
Neck pain recurs and develops within one to five years in 20% of patients and the rate of complete recovery in these cases is very low. Neck pain is the most frequently investigated musculoskeletal problem after low back pain. It is defined as non-specific neck pain due to multifactorial etiology. Many conservative treatment modalities are used in the treatment of NSNP. These include clinical exercises, medical treatments, neural therapy, manual therapy methods, massage, acupuncture, and various physical therapy modalities. Muscle energy techniques (MET) are manual therapy methods that involve soft tissue manipulation using precise and controlled, patient-initiated, isometric, and/or isotonic contractions to improve musculoskeletal function and reduce pain. MET can be used to mobilize a joint with a limited range of motion, lengthen a spastic or shortened muscle, reduce local edema, and strengthen a physiologically weak muscle or muscle group.
Post-isometric relaxation (PIR) is defined as a reduction in the tone of the agonist muscle after an isometric contraction. This technique aims to reduce muscle tension by regulating muscle function and is used to mobilize the restricted joint, reduce edema, and lengthen and strengthen muscles in both subacute and chronic conditions. Studies have also used PIR for neck pain.
The muscle spindle is one of the sensory receptors in skeletal muscle. Its function is to provide proprioceptive information to the cerebral cortex. As the muscle lengthens, the muscle spindle is activated, and a reflex contraction of the agonist muscle and relaxation of the antagonist muscle occurs. This process is known as reciprocal inhibition (RI). Studies using the RI technique in people with neck pain were found. However, no studies were found in people with non-specific neck pain.
Stretching is a general term describing a therapeutic maneuver used to increase the extensibility of soft tissues. Self-stretching (SS) is the self-application of this technique. Studies comparing the effects of MET with different treatment modalities in people with non-specific neck pain were identified in the literature. These trials found similar effects and varying degrees of superiority in reducing pain intensity and increasing range of motion (ROM). In the literature, studies have compared stretching with MET in people with neck pain or compared MET with different treatment methods and examined their effects on variables such as pain and ROM. However, no study was found that compared different METs and self-training in individuals with NSNP and investigated the immediate effect of EMG. Therefore, the aim of our study was to investigate the effect of these techniques. It was thought that the information obtained as a result of the study would guide the creation and development of rehabilitation programs.
The hypotheses of the study are as follows:
Hypothesis 1: The PIR technique applied to individuals with NSNP has a positive effect on pain intensity, pressure pain threshold, range of motion, and muscle activation.
Hypothesis 2: The RI technique applied to individuals with NSNP has a positive effect on pain intensity, pressure pain threshold, range of motion, and muscle activation.
Hypothesis 3: SS technique applied to individuals with NSNP has a positive effect on pain intensity, pressure pain threshold, range of motion, and muscle activation.
Hypothesis 4: Muscle energy techniques applied to individuals with NSNP have more positive effects on pain intensity, pressure pain threshold, range of motion and muscle activation than SS technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-Stretching Exercises Group (SSEG) | Experimental | Other: Self-Streching ExercisesSelf-stretching (SS) is defined as stretching applied by the individual to himself/herself. For this application, firstly the painful area was determined, and stretching was applied to the muscle with pain. Firstly, the participant stood with his/her arm free on the side to be stretched and lateral flexed his/her head. With his/her other hand, he/she applied 10 seconds of stretching in the direction of lateral flexion, a 10-second rest period was given between each stretching, and this method was performed with a total of 10 repetitions. |
| Post-Isometric Relaxation Exercises Group (PIREG) | Experimental | Other: Post-Isometric Relaxation ExercisesPost-isometric relaxation (PIR) was performed by a physiotherapist in a supine position. The physiotherapist sat on the head side of the patient. The painful side was determined, and the physiotherapist fixed the head with his/her hand and performed 50% voluntary isometric contraction of the painful muscle for 10 seconds. Then, the physiotherapist asked the patient to relax and stretch for 10 seconds to lateral flexion. This method was 10 repetitions with 10 seconds of rest between each repetition. |
| Reciprocal-Inhibition Exercises Group (RIEG) | Experimental | Other: Reciprocal-Inhibiton ExercisesReciprocal inhibition (RI) was applied by a physiotherapist in a supine position. The physiotherapist sat on the head side of the patient. The painful side was determined, and the physiotherapist fixed the head with his/her hand and performed 50% voluntary isometric contraction of the antagonist of the painful muscle for 10 seconds. Then physiotherapist asked the patient to relax and stretch for 10 seconds in the lateral flexion direction. This method was 10 repetitions and there were 10 seconds of rest between each repetition. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years or older
- Being a volunteer to participate into the study
- Not having diagnosed orthopedic and neurological problems
- Having Neck pain for at least four months
Key exclusion criteria (8 listed)
- Having diagnosed with active infectious pathology
- Having cervical spine fracture/previous cervical or thoracic surgery
- Having a history of severe trauma to the cervical spine
- Having a history of malignant tumors
- Having diagnosed with structural deformity
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 |
|---|---|---|
| Self-Streching ExercisesAlso: SSEThe participants in the SSE group; received 1 session SSE with 10 repetitions, about 30 min. The assessments were applied before and after the session. | Other | Self-Stretching Exercises Group (SSEG) |
| Post-Isometric Relaxation ExercisesAlso: PIREThe participants in the PIRE group; received 1 session PIRE with 10 repetitions, about 30 min. The assessments were applied before and after the session. | Other | Post-Isometric Relaxation Exercises Group (PIREG) |
| Reciprocal-Inhibiton ExercisesAlso: RIEThe participants in the RIE group; received 1 session RIE with 10 repetitions, about 30 min. The assessments were applied before and after the session. | Other | Reciprocal-Inhibition Exercises Group (RIEG) |
Primary outcome
Assessment of Pain Severity
Time frame: Before and up to 4 weeks
Pain severity was assessed using the Visual Analogue Scale (VAS). The VAS is a subjective pain scale in which the intensity of pain is rated 0-10 cm on a horizontal line. "0" refers to "no pain, while "10" refers to worst pain.
Assessment of Pressure Pain Threshold
Time frame: Before and up to 4 weeks
The Wagner digital algometer (Wagner Instruments) was used to measure the pressure pain threshold (PPT). Trigger points in the upper trapezius and cervical paravertebral muscles were palpated and the most painful trigger points were marked as four separate points on the right and left. The algometer was placed perpendicular to the trigger points and the pressure was increased until the first moment when the patient felt pain and the probe was withdrawn with the expression "I felt it/OK". At this point, the PPT value in Newton read from the algometer was recorded in three repetitions.
Assessment of Range of Motion
Time frame: Before and up to 4 weeks
The subjects' neck ROMs were recorded in degrees by measuring the degrees of flexion, extension, lateral flexion and rotation three times with a manual goniometer while sitting upright in a chair.
Assessment of Muscle Activation
Time frame: Before and up to 4 weeks
Muscle activation was assessed with a MegaWin WBA eight-channel EMG device. Superficial EMG electrodes were placed on the upper trapezius and sternocleidomastoid muscles, right and left. A total of 4 outputs were used, 2 muscles on each side. Myoelectric signals were obtained, and muscular contraction and inhibition were assessed. Additionally, the "IC/MVIC" percentage was calculated to determine the workload on the muscle during the activity.
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 10 Jan 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.
Betul Taspinar, Prof. Dr. principal investigator
Izmir Democracy 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 Self-Streching Exercises, Post-Isometric Relaxation Exercises and Reciprocal-Inhibiton Exercises in people with Nonspecific Neck Pain and Exercise, run by Izmir Democracy 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 8 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 10 Jan 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?
Assessment of Pain Severity (time frame: Before and up to 4 weeks). 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 10 Jan 2024.