Neck PainMET&SSinNckpNCT04350918
Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain
A study testing Muscle Enery Techniques and Static Stretching in people with Neck Pain, run by Obafemi Awolowo University at 1 site in Nigeria.
Trial summary
Neck pain is becoming increasingly common throughout the world with a considerable impact on individuals, communities, health-care systems and businesses (Hoy et al, 2011).Neck pain is a common problem within our society affecting individual's physical and social functioning considerably and interfering with the… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Muscle Enery Techniques and Static Stretching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNigeria
- Study dates
- 23 May 2019to 16 Jan 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with acute neck pain
- Subjects were excluded if they have neck pain associated with an underlying pathology such as fracture of the cervical spine, neck pain radiating into the arms or upper extremity or associated with headaches or facial pain, malignancy, infections, inflammatory disorders, osteoporosis or cases of disc prolapse.
- Patients with history of surgery of the cervical spine during the previous 12months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain: A Randomized Control Study
Neck pain is becoming increasingly common throughout the world with a considerable impact on individuals, communities, health-care systems and businesses (Hoy et al, 2011).Neck pain is a common problem within our society affecting individual's physical and social functioning considerably and interfering with the patient's daily activities. There is lack of evidence to allow conclusions to be drawn about the effectiveness of MET when compared with stretching exercises for relieving mechanical neck pain. Therefore, this study is designed to examine the effect of MET, static stretching and to compare their effects on pain intensity and functional disability in patient with mechanical neck pain.
Read the detailed description
This experimental study purposively recruited 24 subjects (male: n=10, female: n = 14) with mechanical neck pain from the Outpatient Physiotherapy Department of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife. Subjects were randomly allocated into the MET and SS groups. Subjects in MET group received 6 treatment sessions of Muscle Energy Technique in addition to conventional physiotherapy treatments. Patients in SS group received 6 treatment sessions of Static Stretching in addition to conventional physiotherapy treatments. All subjects were treated twice a week for six weeks. Visual Analogue Scale (VAS) and Neck Disability Index (NDI) were used to assess the pain intensity and functional disability at baseline, 3rd week and 6th week of treatment sessions respectively. Descriptive and Inferential statistics were used to analyse the data. Alpha level was set at < 0.05.
- Conditions
- Neck Pain
- Being tested
- Muscle Enery Techniques, Static Stretching
- Keywords
- Static stretching, ,, neck pain,, muscle energy techniques, visual analogue scale,, neck disability index
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Enery TechniquesDevice
Also called MET
Group of patients that underwent muscle energy technique as a mean of treatment for the complaint
Static StretchingDevice
Also called SS
Set of patients that had static stretching technique for the treatment for the complaint
| Study group | Role | What they receive |
|---|---|---|
| Muscle Energy Technique (MET) | Experimental | MET Group received 12 treatment sessions of MET (Nagrale et al, 2010) two times a week in addition to conventional physiotherapy. The procedures employ voluntary muscle contractions by the patient in a precisely controlled direction and intensity against a counterforce applied by the Physiotherapist. The technique requires the therapist to provide stabilization to the segment on which the distal aspect of the muscle attaches. A command for anisometric contraction of the muscle is given that causes accessory movement of the joint. Several specific muscle energy techniques are described for the subcranial region of the cervical spine. Receives: Device: Muscle Enery Techniques |
| Static stretching (SS) | Experimental | Subjects in SS Group received 12 treatment sessions of static stretching (Dutton et al, 2008) two times a week in addition to conventional physiotherapy.
Stretching involves the application of manual or mechanical force to elongate structures that have adaptively shortened and are hypo-mobile (Sullivan, 2007) Static stretching involves stretching a muscle to a point of discomfort and holding the stretch for a length of time, followed by a return to normal resting muscle length (Andrews et al, 2004). Muscles of the neck were stretched in especially in side flexion, extension, flexion and side rotation for 10 seconds and was repeated 10 times for a session. Receives: Device: Static Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
VAS is a one-dimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases (Mc Cormack et al, 1988). pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) (Aun et al, 1986)
Measured: From March 2019 to November 2019, The treatment for each patient was for 6 weeks
Secondary outcomes (1)
Neck Disability Index (NDI)
The NDI can be scored as a raw score or doubled and expressed as a percent (Vernon, 1991). Each session is scored on a 0 to 5 rating scale, in which zero means 'No Pain' and 5 means 'Worst Imaginable Pain'. All the points can be summarized as a total score. The test can be interpreted as a raw score with a maximum score of 50 or as a percentage.
Measured: From March 2019 to November 2019, The treatment for each patient was for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start23 May 2019
- Primary completion24 Dec 2019
- Study completion16 Jan 2020
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
- Subjects for this study were patients diagnosed of mechanical neck pain in Physiotherapy Outpatient Department of Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile-Ife. Individuals who meet the inclusion criteria were randomly allocated to Muscle Energy Techniques Group and Static Stretching Group using the simple random assignment method without replacement (Fish Bowl).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adesola Ojo Ojoawo, Obafemi Awolowo University
- Investigators
- Adesola O Ojoawo PhD, Principal investigator, Head, Department of Medical Rehabilitation, Obafemi Awolowo University Ile IfeKayode Ijaduola, Study chair, Provost, College of Health Sciences, Obafemi Awolowo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350918
- Sponsor's protocol ID
- OJO/2020/01
- Acronym
- MET&SSinNckp
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT04350918
- Acronym / sponsor ID
- MET&SSinNckp / OJO/2020/01
- Conditions
- Neck Pain
- Keywords
- Static stretching, ,, neck pain,, muscle energy techniques, visual analogue scale,, neck disability index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 17 Apr 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.
Neck pain is becoming increasingly common throughout the world with a considerable impact on individuals, communities, health-care systems and businesses (Hoy et al, 2011).Neck pain is a common problem within our society affecting individual's physical and social functioning considerably and interfering with the patient's daily activities. There is lack of evidence to allow conclusions to be drawn about the effectiveness of MET when compared with stretching exercises for relieving mechanical neck pain. Therefore, this study is designed to examine the effect of MET, static stretching and to compare their effects on pain intensity and functional disability in patient with mechanical neck pain.
Detailed description
This experimental study purposively recruited 24 subjects (male: n=10, female: n = 14) with mechanical neck pain from the Outpatient Physiotherapy Department of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife. Subjects were randomly allocated into the MET and SS groups. Subjects in MET group received 6 treatment sessions of Muscle Energy Technique in addition to conventional physiotherapy treatments. Patients in SS group received 6 treatment sessions of Static Stretching in addition to conventional physiotherapy treatments. All subjects were treated twice a week for six weeks. Visual Analogue Scale (VAS) and Neck Disability Index (NDI) were used to assess the pain intensity and functional disability at baseline, 3rd week and 6th week of treatment sessions respectively. Descriptive and Inferential statistics were used to analyse the data. Alpha level was set at < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects for this study were patients diagnosed of mechanical neck pain in Physiotherapy Outpatient Department of Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile-Ife. Individuals who meet the inclusion criteria were randomly allocated to Muscle Energy Techniques Group and Static Stretching Group using the simple random assignment method without replacement (Fish Bowl).
| Arm | Type | Receives |
|---|---|---|
| Muscle Energy Technique (MET) | Experimental | Device: Muscle Enery TechniquesMET Group received 12 treatment sessions of MET (Nagrale et al, 2010) two times a week in addition to conventional physiotherapy. The procedures employ voluntary muscle contractions by the patient in a precisely controlled direction and intensity against a counterforce applied by the Physiotherapist. The technique requires the therapist to provide stabilization to the segment on which the distal aspect of the muscle attaches. A command for anisometric contraction of the muscle is given that causes accessory movement of the joint. Several specific muscle energy techniques are described for the subcranial region of the cervical spine. |
| Static stretching (SS) | Experimental | Device: Static StretchingSubjects in SS Group received 12 treatment sessions of static stretching (Dutton et al, 2008) two times a week in addition to conventional physiotherapy. Stretching involves the application of manual or mechanical force to elongate structures that have adaptively shortened and are hypo-mobile (Sullivan, 2007) Static stretching involves stretching a muscle to a point of discomfort and holding the stretch for a length of time, followed by a return to normal resting muscle length (Andrews et al, 2004). Muscles of the neck were stretched in especially in side flexion, extension, flexion and side rotation for 10 seconds and was repeated 10 times for a session. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients with acute neck pain
- Subjects were excluded if they have neck pain associated with an underlying pathology such as fracture of the cervical spine, neck pain radiating into the arms or upper extremity or associated with headaches or facial pain, malignancy, infections, inflammatory disorders, osteoporosis or cases of disc prolapse.
- Patients with history of surgery of the cervical spine during the previous 12months
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 |
|---|---|---|
| Muscle Enery TechniquesAlso: METGroup of patients that underwent muscle energy technique as a mean of treatment for the complaint | Device | Muscle Energy Technique (MET) |
| Static StretchingAlso: SSSet of patients that had static stretching technique for the treatment for the complaint | Device | Static stretching (SS) |
Primary outcome
Visual Analogue Scale
Time frame: From March 2019 to November 2019, The treatment for each patient was for 6 weeks
VAS is a one-dimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases (Mc Cormack et al, 1988). pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) (Aun et al, 1986)
1 secondary outcome
Neck Disability Index (NDI)
Time frame: From March 2019 to November 2019, The treatment for each patient was for 6 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 20 Apr 2020.
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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.
Adesola O Ojoawo PhD principal investigator
Head, Department of Medical Rehabilitation, Obafemi Awolowo University Ile Ife
Kayode Ijaduola study chair
Provost, College of Health Sciences, Obafemi Awolowo 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 Muscle Enery Techniques and Static Stretching in people with Neck Pain, run by Obafemi Awolowo University at 1 site in Nigeria.
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 0 inclusion and 3 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 20 Apr 2020. 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 Nigeria. 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 (time frame: From March 2019 to November 2019, The treatment for each patient was for 6 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 20 Apr 2020.