Neck PainNCT06200064
Physiotherapy for Non-specific Neck Pain in Working Age Persons
A study testing Self-stretching exercise group and Post-isometric relaxation exercise group in people with Neck Pain and Non-specific Neck Pain, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
The goal of this clinical trial is to learn about the effects of two different physiotherapy methods on non-specific neck pain in working age individuals. The main questions it aims to answer are: What is the effect of self stretching exercise on non-specific neck pain, functional disability, range of motion of the… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Neck Pain, Non-specific Neck Pain
- What is being tested?
- Self-stretching exercise group and Post-isometric relaxation exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Oct 2023to 15 Dec 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- current neck pain,
- neck pain duration for at least 12 weeks,
- admission through outpatient clinic in Lithuania.
Who cannot join
- neurological disorders related to neck pain,
- red flags (night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch),
- previous neck surgery,
- low back pain,
- medications used for pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of Post Isometric Relaxation and Self-stretching on Non-specific Neck Pain in Working Age Persons
The goal of this clinical trial is to learn about the effects of two different physiotherapy methods on non-specific neck pain in working age individuals. The main questions it aims to answer are:
- What is the effect of self stretching exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals?
- What is the effect of post-isometric relaxation exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals?
- Is any of the applied interventions (self-stretching or post-isometric relaxation exercise) superior to each other?
Read more
Participants will:
- be evaluated by an experienced physiotherapist who will perform the interview and physical examination. Interview includes questions about the age, sex, work profile, pain intensity and duration, and other complaints. Physiotherapy examination includes a range of motion measurement, hand grip muscle strength and functional disability index evaluation.
- Two different interventions will be prescribed to the randomly assigned study participants: post-isometric relaxation and self-stretching. Duration of interventions for both groups is 4 weeks (3 times per week, 12 sessions). Duration of one session - 45 min.
Read the detailed description
The goal of this clinical trial is to learn about the effects of two different physiotherapy methods on non-specific neck pain in working age individuals. The main questions it aims to answer are:
What is the effect of self stretching exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals? What is the effect of post-isometric relaxation exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals? Is any of the applied interventions (self-stretching or post-isometric relaxation exercise) superior to each other?
Participants will:
be evaluated by an experienced physiotherapist who will perform the interview and physical examination. Interview includes questions about the age, sex, work profile, pain intensity and duration, and other complaints. Physiotherapy examination includes a range of motion measurement, hand grip muscle strength and functional disability index evaluation.
Two different interventions will be prescribed to the randomly assigned study participants: post-isometric relaxation and self-stretching. Duration of interventions for both groups is 4 weeks (3 times per week, 12 sessions). Duration of one session - 45 min.
- Conditions
- Neck Pain, Non-specific Neck Pain
- Being tested
- Self-stretching exercise group, Post-isometric relaxation exercise group
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-stretching exercise groupOther
Static neck muscle self-stretching exercises were performed for 30 min. after the TENS procedure. Every muscle in the neck region (head rotator cuff, neck stair muscles, upper part of the trapezius muscle, scapula levator muscle, semiscapular neck muscle, upper oblique head muscle, girdle head and neck muscles, and deep anterior neck flexor muscles) were stretched 3 times for 30 seconds per muscle group. While performing exercises, the subjects applied resistance with their hands. All exercises were performed without causing pain.
Post-isometric relaxation exercise groupOther
The investigators used one of the autogenic inhibition techniques - post-isometric relaxation (PIR), known as the muscle "contraction-relaxation" technique, during which, the subject is lying on his back, he is asked to press his head in the specified direction (50% of the subject's maximum pressure force). to the resistance provided by the therapist. During the press, resistance was provided for 10 seconds and followed by a passive stretch of the muscle in the opposite direction of movement. A total of 5 repetitions are performed for each muscle with a 5-second break. All movements are performed without causing pain of more than moderate intensity.
| Study group | Role | What they receive |
|---|---|---|
| Self-stretching exercise group | Experimental | Static neck muscle self-stretching exercises were performed for 30 min. after the TENS procedure. Every muscle in the neck region (head rotator cuff, neck stair muscles, upper part of the trapezius muscle, scapula levator muscle, semiscapular neck muscle, upper oblique head muscle, girdle head and neck muscles, and deep anterior neck flexor muscles) were stretched 3 times for 30 seconds per muscle group. While performing exercises, the subjects applied resistance with their hands. All exercises were performed without causing pain. Receives: Other: Self-stretching exercise group |
| Post-isometric relaxation exercise group | Experimental | The investigators used one of the autogenic inhibition techniques - post-isometric relaxation (PIR), known as the muscle "contraction-relaxation" technique, during which, the subject is lying on his back, he is asked to press his head in the specified direction (50% of the subject's maximum pressure force). to the resistance provided by the therapist. During the press, resistance was provided for 10 seconds and followed by a passive stretch of the muscle in the opposite direction of movement. A total of 5 repetitions are performed for each muscle with a 5-second break. All movements are performed without causing pain of more than moderate intensity. Receives: Other: Post-isometric relaxation exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Neck pain intensity was assessed using a visual analogue scale (VAS) on a 10-cm line with end-point descriptors such as 'no pain' marked at the left end and 'worst pain imaginable' marked at the right end. Patients were asked to mark a point on the line that best represented their pain at the time of the evaluation. The distance from 'no pain' to the patient's mark was then measured and recorded as the VAS score: 0 cm was defined as no pain, 1-3 cm as mild pain, 4 or 5 cm as moderate pain, 6-8 cm as severe pain and 9 or 10 cm as the worst pain imaginable.
Measured: Change from Baseline Quality of Life at 4 weeks
Secondary outcomes (3)
Cervical spine range of motion
ROM was measured using bubble inclinometer, which was placed on the top of the patient's head, along the sagittal plane to measure neck flexion and extension, when the patient was in sitting position. Side bending was measured from the same starting position just as the inclinometer was placed in the frontal plane on the top of the patient's head. Rotations to the left and right were taken from the supine position with an inclinometer placed on the forehead. The inclinometer's reading at the starting position was 0. The readings of ROM were taken when the end point of movement was reached. In our study, three repetitions were performed in each direction, and the average value was taken for analysis.
Measured: Change from Baseline Quality of Life at 4 weeks
Hand grip strength
Hand grip strength was measured using a hand dynamometer (Saehan SH5001, Germany). Grip strength of the dominant and non-dominant hand was measured when seated with the shoulder neutrally rotated and adducted, the elbow flexed at 90°, and the wrist and forearm in a neutral position. The maximum grip strength was measured in kilograms (kg). Three measurements were taken with 60 s rest between each trial and the average result was recorded.
Measured: Change from Baseline Quality of Life at 4 weeks
The Neck Disability Index
The Neck Disability Index (NDI) questionnaire consists of 10 items. Each item on the scale is scored from 0 to 5, where all the scores are added to total points and interpreted as percentages i.e., 0 point or 0% means no activity limitation, and 50 points or 100% means complete activity limitation. The NDI is a reliable and valid questionnaire in neck pain patients with intraclass correlation ranges between 0.50-0.98. Patients scored between 0-4 points (0-8%) are considered with no disability, between 5-14 points (10-28%) with mild disability, 15-24 points (30-48%) - moderate disability, 25-34 points (50- 64%) - severe disability, and 35-50 points (70-100%) - complete disability
Measured: Change from Baseline Quality of Life at 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 start1 Oct 2023
- Primary completion30 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- This study is a four week, single blinded randomized controlled trial with pre-post design comparing self-stretching exercise group with post-isometric relaxation exercise group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vilma Dudoniene, Lithuanian Sports University
- Investigators
- Vilma Dudoniene, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200064
- Sponsor's protocol ID
- LithuanianSportsU-19
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Post Isometric Relaxation and Self-stretching on Non-specific Neck Pain in Working Age Persons
- ClinicalTrials.gov ID
- NCT06200064
- Acronym / sponsor ID
- LithuanianSportsU-19
- Conditions
- Neck Pain, Non-specific Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 15 Dec 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.
The goal of this clinical trial is to learn about the effects of two different physiotherapy methods on non-specific neck pain in working age individuals. The main questions it aims to answer are:
- What is the effect of self stretching exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals?
- What is the effect of post-isometric relaxation exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals?
- Is any of the applied interventions (self-stretching or post-isometric relaxation exercise) superior to each other?
Participants will:
- be evaluated by an experienced physiotherapist who will perform the interview and physical examination. Interview includes questions about the age, sex, work profile, pain intensity and duration, and other complaints. Physiotherapy examination includes a range of motion measurement, hand grip muscle strength and functional disability index evaluation.
- Two different interventions will be prescribed to the randomly assigned study participants: post-isometric relaxation and self-stretching. Duration of interventions for both groups is 4 weeks (3 times per week, 12 sessions). Duration of one session - 45 min.
Detailed description
The goal of this clinical trial is to learn about the effects of two different physiotherapy methods on non-specific neck pain in working age individuals. The main questions it aims to answer are:
What is the effect of self stretching exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals? What is the effect of post-isometric relaxation exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals? Is any of the applied interventions (self-stretching or post-isometric relaxation exercise) superior to each other?
Participants will:
be evaluated by an experienced physiotherapist who will perform the interview and physical examination. Interview includes questions about the age, sex, work profile, pain intensity and duration, and other complaints. Physiotherapy examination includes a range of motion measurement, hand grip muscle strength and functional disability index evaluation.
Two different interventions will be prescribed to the randomly assigned study participants: post-isometric relaxation and self-stretching. Duration of interventions for both groups is 4 weeks (3 times per week, 12 sessions). Duration of one session - 45 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a four week, single blinded randomized controlled trial with pre-post design comparing self-stretching exercise group with post-isometric relaxation exercise group.
| Arm | Type | Receives |
|---|---|---|
| Self-stretching exercise group | Experimental | Other: Self-stretching exercise groupStatic neck muscle self-stretching exercises were performed for 30 min. after the TENS procedure. Every muscle in the neck region (head rotator cuff, neck stair muscles, upper part of the trapezius muscle, scapula levator muscle, semiscapular neck muscle, upper oblique head muscle, girdle head and neck muscles, and deep anterior neck flexor muscles) were stretched 3 times for 30 seconds per muscle group. While performing exercises, the subjects applied resistance with their hands. All exercises were performed without causing pain. |
| Post-isometric relaxation exercise group | Experimental | Other: Post-isometric relaxation exercise groupThe investigators used one of the autogenic inhibition techniques - post-isometric relaxation (PIR), known as the muscle "contraction-relaxation" technique, during which, the subject is lying on his back, he is asked to press his head in the specified direction (50% of the subject's maximum pressure force). to the resistance provided by the therapist. During the press, resistance was provided for 10 seconds and followed by a passive stretch of the muscle in the opposite direction of movement. A total of 5 repetitions are performed for each muscle with a 5-second break. All movements are performed without causing pain of more than moderate intensity. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- current neck pain,
- neck pain duration for at least 12 weeks,
- admission through outpatient clinic in Lithuania.
Key exclusion criteria (5 listed)
- neurological disorders related to neck pain,
- red flags (night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch),
- previous neck surgery,
- low back pain,
- medications used for pain.
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-stretching exercise groupStatic neck muscle self-stretching exercises were performed for 30 min. after the TENS procedure. Every muscle in the neck region (head rotator cuff, neck stair muscles, upper part of the trapezius muscle, scapula levator muscle, semiscapular neck muscle, upper oblique head muscle, girdle head and neck muscles, and deep anterior neck flexor muscles) were stretched 3 times for 30 seconds per muscle group. While performing exercises, the subjects applied resistance with their hands. All exercises were performed without causing pain. | Other | Self-stretching exercise group |
| Post-isometric relaxation exercise groupThe investigators used one of the autogenic inhibition techniques - post-isometric relaxation (PIR), known as the muscle "contraction-relaxation" technique, during which, the subject is lying on his back, he is asked to press his head in the specified direction (50% of the subject's maximum pressure force). to the resistance provided by the therapist. During the press, resistance was provided for 10 seconds and followed by a passive stretch of the muscle in the opposite direction of movement. A total of 5 repetitions are performed for each muscle with a 5-second break. All movements are performed without causing pain of more than moderate intensity. | Other | Post-isometric relaxation exercise group |
Primary outcome
Pain intensity
Time frame: Change from Baseline Quality of Life at 4 weeks
Neck pain intensity was assessed using a visual analogue scale (VAS) on a 10-cm line with end-point descriptors such as 'no pain' marked at the left end and 'worst pain imaginable' marked at the right end. Patients were asked to mark a point on the line that best represented their pain at the time of the evaluation. The distance from 'no pain' to the patient's mark was then measured and recorded as the VAS score: 0 cm was defined as no pain, 1-3 cm as mild pain, 4 or 5 cm as moderate pain, 6-8 cm as severe pain and 9 or 10 cm as the worst pain imaginable.
3 secondary outcomes
Cervical spine range of motion
Time frame: Change from Baseline Quality of Life at 4 weeks
Hand grip strength
Time frame: Change from Baseline Quality of Life at 4 weeks
The Neck Disability Index
Time frame: Change from Baseline Quality of Life at 4 weeks
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 12 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.
Vilma Dudoniene principal investigator
Lithuanian Sports 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-stretching exercise group and Post-isometric relaxation exercise group in people with Neck Pain and Non-specific Neck Pain, run by Lithuanian Sports University at 1 site in Lithuania.
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 3 inclusion and 5 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 12 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 Lithuania. 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?
Pain intensity (time frame: Change from Baseline Quality of Life at 4 weeks). 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 12 Jan 2024.