Non Specific Neck PainNCT05654688
NONSPECIFIC NECK PAIN
A study testing graston and muscle energy technique in people with Non Specific Neck Pain, run by Helwan University at 1 site in Egypt.
Trial summary
The goal of this a randomized control trial is to carried out to examine Graston technique (GT) and muscle energy method (MET) impact on nonspecific neck pain compared to traditional physiotherapy treatment (TPT), This study aims to contrast between the outcomes of GT and MET on both pain intensity and functional… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Non Specific Neck Pain
- What is being tested?
- graston and muscle energy technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Nov 2022
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- non specific neck pain
Who cannot join
- Symptoms or signs of upper motor neuron disease, vestibulobasilar insufficiency, and amyotrophic lateral sclerosis.
- Cervical spine fracture. Cases of disc prolapse that have been diagnosed. prior cervical or thoracic spine surgery, (28).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GRASTON VERSUS MUSCLE ENERGY TECHNIQUE IN NONSPECIFIC NECK PAIN
The goal of this a randomized control trial is to carried out to examine Graston technique (GT) and muscle energy method (MET) impact on nonspecific neck pain compared to traditional physiotherapy treatment (TPT), This study aims to contrast between the outcomes of GT and MET on both pain intensity and functional disability in patients. Each participant was assigned a unique number, and then those numbers were randomly divided into three groups. Three groups were formed from a random selection of participants: GT Group (A): received 12 sessions of GT and (TPT) over the course of four weeks (three sessions per week). MET Group (B): received 12 sessions of MET treatment and (TPT) over a period of four weeks (three sessions per week). Control Group (C): received 12 sessions of traditional physiotherapy (TPT) over a period of four weeks (three sessions per week).
Read the detailed description
Pain intensity (VAS) It was utilized to evaluate the degree of pain both before and after treatment. Subjects were asked to rate their pain on a scale from 0 (no pain) to 10 (extreme pain). Specifically, a line representing 10 centimeters was used as the scale's visual representation. Distance from zero to the respondent's mark was then used to approximate the sufferer's level of discomfort.
Functional Disability (NDI) The Neck Disability Index (NDI) is a 10-item questionnaire used to assess the functional impairment caused by neck pain. The questionnaire covers a wide range of topics related to one's everyday life, including but not limited to: personal care, heavy lifting, work, driving, sleeping, playing, recreational, pain level, concentration, and headache. Scores range from 0 (no disability) to 5 (severe disability) for each question, with the total score out of 100 determined by adding and doubling the scores for each question. If a patient has a high NDI score, they report being more disabled as a result of their neck pain. Patients have identified a 5-10% improvement as the "minimally clinically meaningful change." This study excluded any patient with: Symptoms or signs of upper motor neuron disease, vestibulobasilar insufficiency, and amyotrophic lateral sclerosis. Cervical spine fracture, Cases of disc prolapse that have been diagnosed (27), prior cervical or thoracic spine surgery.
- Conditions
- Non Specific Neck Pain
- Being tested
- graston and muscle energy technique
- Keywords
- GRASTON TECHNIQUE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
graston and muscle energy techniqueOther
Graston technique (Gt) is a technique of mobilization of soft tissue using instruments which consider myofascial release instrument that has been reported to relieve pain, improve overall function, and increase range of motion.
Muscle energy technique (MET) is a term composed of various types of active muscular relaxation and stretching procedures. The two cornerstone forms of MET are reciprocal inhibition and post isometric relaxation. In theory, reciprocal inhibition takes advantage of the neurological phenomena of muscular contraction, which results in an inhibitory effect on the antagonistic muscles.
| Study group | Role | What they receive |
|---|---|---|
| Graston | Experimental | Graston technique and traditional physical treatment (control) Receives: Other: graston and muscle energy technique |
| Muscle energy technique | Experimental | Muscle energy technique and traditional physical treatment Receives: Other: graston and muscle energy technique |
| Traditional physical therapy | Active comparator | Traditional physical therapy treatment as heat application Receives: Other: graston and muscle energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (VAS)
Pain intensity (VAS) It was utilized to evaluate the degree of pain both before and after treatment. Subjects were asked to rate their pain on a scale from 0 (no pain) to 10 (extreme pain). Specifically, a line representing 10 centimeters was used as the scale's visual representation. Distance from zero to the respondent's mark was then used to approximate the sufferer's level of discomfort
Measured: 1 month
Secondary outcomes (1)
Functional Disability (NDI)
Functional Disability (NDI) The Neck Disability Index (NDI) is a 10-item questionnaire used to assess the functional impairment caused by neck pain. The questionnaire covers a wide range of topics related to one's everyday life, including but not limited to: personal care, heavy lifting, work, driving, sleeping, playing, recreational, pain level, concentration, and headache. Scores range from 0 (no disability) to 5 (severe disability) for each question, with the total score out of 100 determined by adding and doubling the scores for each question. If a patient has a high NDI score, they report being more disabled as a result of their neck pain. Patients have identified a 5-10% improvement as the "minimally clinically meaningful change."
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Apr 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Specific 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- .Design: A randomized controlled experimental pre-post measurement. This study included forty two (30 males and 12 females) patients with NSNP aged between the ages of 40 and 60. Each participant was assigned a unique number, and then those numbers were randomly divided into three groups. Three groups were formed from a random selection of participants: GT Group (A): received 12 sessions of GT and (TPT) over the course of four weeks (three sessions per week). MET Group (B): received 12 sessions of MET treatment and (TPT) over a period of four weeks (three sessions per week). Control Group (C): received 12 sessions of traditional physiotherapy (TPT) over a period of four weeks (three sessions per week).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsayed, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654688
- Sponsor's protocol ID
- HelwanU
- Status last verified
- Nov 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCormack JR, Underwood FB, Slaven EJ, Cappaert TA. Eccentric Exercise Versus Eccentric Exercise and Soft Tissue Treatment (Astym) in the Management of Insertional Achilles Tendinopathy. Sports Health. 2016 May/Jun;8(3):230-237. doi: 10.1177/1941738116631498.
PubMed 26893309
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRASTON VERSUS MUSCLE ENERGY TECHNIQUE IN NONSPECIFIC NECK PAIN
- ClinicalTrials.gov ID
- NCT05654688
- Acronym / sponsor ID
- HelwanU
- Conditions
- Non Specific Neck Pain
- Keywords
- GRASTON TECHNIQUE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 16 Dec 2022 (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 a randomized control trial is to carried out to examine Graston technique (GT) and muscle energy method (MET) impact on nonspecific neck pain compared to traditional physiotherapy treatment (TPT), This study aims to contrast between the outcomes of GT and MET on both pain intensity and functional disability in patients. Each participant was assigned a unique number, and then those numbers were randomly divided into three groups. Three groups were formed from a random selection of participants: GT Group (A): received 12 sessions of GT and (TPT) over the course of four weeks (three sessions per week). MET Group (B): received 12 sessions of MET treatment and (TPT) over a period of four weeks (three sessions per week). Control Group (C): received 12 sessions of traditional physiotherapy (TPT) over a period of four weeks (three sessions per week).
Detailed description
Pain intensity (VAS) It was utilized to evaluate the degree of pain both before and after treatment. Subjects were asked to rate their pain on a scale from 0 (no pain) to 10 (extreme pain). Specifically, a line representing 10 centimeters was used as the scale's visual representation. Distance from zero to the respondent's mark was then used to approximate the sufferer's level of discomfort.
Functional Disability (NDI) The Neck Disability Index (NDI) is a 10-item questionnaire used to assess the functional impairment caused by neck pain. The questionnaire covers a wide range of topics related to one's everyday life, including but not limited to: personal care, heavy lifting, work, driving, sleeping, playing, recreational, pain level, concentration, and headache. Scores range from 0 (no disability) to 5 (severe disability) for each question, with the total score out of 100 determined by adding and doubling the scores for each question. If a patient has a high NDI score, they report being more disabled as a result of their neck pain. Patients have identified a 5-10% improvement as the "minimally clinically meaningful change." This study excluded any patient with: Symptoms or signs of upper motor neuron disease, vestibulobasilar insufficiency, and amyotrophic lateral sclerosis. Cervical spine fracture, Cases of disc prolapse that have been diagnosed (27), prior cervical or thoracic spine surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- .Design: A randomized controlled experimental pre-post measurement. This study included forty two (30 males and 12 females) patients with NSNP aged between the ages of 40 and 60. Each participant was assigned a unique number, and then those numbers were randomly divided into three groups. Three groups were formed from a random selection of participants: GT Group (A): received 12 sessions of GT and (TPT) over the course of four weeks (three sessions per week). MET Group (B): received 12 sessions of MET treatment and (TPT) over a period of four weeks (three sessions per week). Control Group (C): received 12 sessions of traditional physiotherapy (TPT) over a period of four weeks (three sessions per week).
| Arm | Type | Receives |
|---|---|---|
| Graston | Experimental | Other: graston and muscle energy techniqueGraston technique and traditional physical treatment (control) |
| Muscle energy technique | Experimental | Other: graston and muscle energy techniqueMuscle energy technique and traditional physical treatment |
| Traditional physical therapy | Active comparator | Other: graston and muscle energy techniqueTraditional physical therapy treatment as heat application |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- non specific neck pain
Key exclusion criteria (2 listed)
- Symptoms or signs of upper motor neuron disease, vestibulobasilar insufficiency, and amyotrophic lateral sclerosis.
- Cervical spine fracture. Cases of disc prolapse that have been diagnosed. prior cervical or thoracic spine surgery, (28).
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 |
|---|---|---|
| graston and muscle energy techniqueGraston technique (Gt) is a technique of mobilization of soft tissue using instruments which consider myofascial release instrument that has been reported to relieve pain, improve overall function, and increase range of motion. Muscle energy technique (MET) is a term composed of various types of active muscular relaxation and stretching procedures. The two cornerstone forms of MET are reciprocal inhibition and post isometric relaxation. In theory, reciprocal inhibition takes advantage of the neurological phenomena of muscular contraction, which results in an inhibitory effect on the antagonistic muscles. | Other | Graston, Muscle energy technique, Traditional physical therapy |
Primary outcome
Pain intensity (VAS)
Time frame: 1 month
Pain intensity (VAS) It was utilized to evaluate the degree of pain both before and after treatment. Subjects were asked to rate their pain on a scale from 0 (no pain) to 10 (extreme pain). Specifically, a line representing 10 centimeters was used as the scale's visual representation. Distance from zero to the respondent's mark was then used to approximate the sufferer's level of discomfort
1 secondary outcome
Functional Disability (NDI)
Time frame: 1 month
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 16 Dec 2022.
- Results publication: PubMed 26893309McCormack JR, Underwood FB, Slaven EJ, Cappaert TA. Eccentric Exercise Versus Eccentric Exercise and Soft Tissue Treatment (Astym) in the Management of Insertional Achilles Tendinopathy. Sports Health. 2016 May/Jun;8(3):230-237. doi: 10.1177/1941738116631498.
- Individual participant dataSharing planned: No
Related trials for Non Specific Neck Pain
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Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
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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 graston and muscle energy technique in people with Non Specific Neck Pain, run by Helwan University at 1 site in Egypt.
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 1 inclusion and 2 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 16 Dec 2022. 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 Egypt. 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 (VAS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654688, which also lists 1 linked publication.
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 16 Dec 2022.