Neck PainNCT05730426
Comparison Between Deep Dry Needling and Muscle Energy Technique on Chronic Non-specific Neck Pain Patients.
A study testing Deep dry needling, Muscle energy technique and Neck stability exercise in people with Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare between applying deep dry needling and muscle energy technique in chronic non-specific neck pain patients. Researchers will compare between deep dry needling group, muscle energy technique group and control group to see if there are change in pain, range of motion or… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Deep dry needling, Muscle energy technique and Neck stability exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Feb 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 and 40 years.
- Current neck pain.
- Presence of at least one or two trigger points .
- Patients are diagnosed and referred from orthopedist complaining from chronic neck pain for at least 12 weeks.
- No clinical treatment for neck pain within the past month.
- lacked a history of neck and shoulder myopathy, neuropathy, myelopathy and neck, torso and shoulder surgery.
- Patients with body mass index less than 30 kg/m2.
Who cannot join
- Patients outside the target range.
- Neck pain associated with vertigo.
- Osteoporosis.
- Diagnosed psychological disorders.
- Fibromyalgia syndrome.
- Vertebral fractures.
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- Spinal stenosis.
- Tumors.
- Previous neck surgery.
- Red flags (night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch).
- Physiotherapeutic treatment continued in the last 3 months. Any contraindications for deep dry needling such as anticoagulants, infections and bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Dry Needling Versus Muscle Energy Technique on Chronic Non-specific Neck Pain; a Randomized Controlled Trial.
The goal of this clinical trial is to compare between applying deep dry needling and muscle energy technique in chronic non-specific neck pain patients. Researchers will compare between deep dry needling group, muscle energy technique group and control group to see if there are change in pain, range of motion or function.
- Conditions
- Neck Pain
- Being tested
- Deep dry needling, Muscle energy technique, Neck stability exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep dry needlingProcedure or surgery
Method to decrease pain and improve function in musculoskeletal disorders.
Muscle energy techniqueProcedure or surgery
Also called Post isometric relaxation
Method to decrease pain and improve function in musculoskeletal disorders.
Neck stability exerciseProcedure or surgery
Method to decrease pain and improve function in musculoskeletal disorders.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | In addition to Transcutaneous Electrical Nerve Stimulation (TENS) (typical,100 Hz, 20 mins), Infrared (7 mins), and Exercises (Cervical Stability Exercises through activation of deep neck flexors), patients received deep dry needling on active trigger points in selected muscles (upper trapezius, levator scapulae, and sternocleidomastoid ), 3 sessions/week, for 4 weeks period. Receives: Procedure: Deep dry needling |
| Group B | Active comparator | In addition to Transcutaneous Electrical Nerve Stimulation (TENS) (typical,100 Hz, 20 mins), Infrared (7 mins), and Exercises (Cervical Stability Exercises through activation of deep neck flexors), patients received muscle energy technique (post isometric relaxation) in selected muscles (upper trapezius, levator scapulae, and sternocleidomastoid ), 3 sessions/week, for 4 weeks period. Receives: Procedure: Muscle energy technique |
| Group C | Placebo comparator | Patients receive Transcutaneous Electrical Nerve Stimulation (TENS) (typical,100 Hz, 20 mins), Infrared (7 mins), and Exercises (Cervical Stability Exercises through activation of deep neck flexors) , 3 sessions/week, for 4 weeks period. Receives: Procedure: Neck stability exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity from baseline to 4 weeks after.
Visual Analogue scale (VAS)
- A value of 0 denotes no pain, whereas a value of 1 to 3 indicates mild pain.
- 4 to 6 denotes moderate pain.
- 7 to 10 denotes intense pain.
Measured: at baseline and after 4 weeks from the baseline.
Change in function from baseline to 4 weeks after.
The Neck Disability Index (NDI) The NDI questionnaire (scored out of 50) was used to measure the patient's perceived disability resulting from their neck pain. The score for each section was from 0 to 5, with 0 represented the highest level of function and 5 represented the lowest level of function. Total NDI scores were shown as a percentage. A high score corresponded to a higher degree of disability.
- 0-4points (0-8%) no disability.
- 5-14points (10 - 28%) mild disability.
- 15-24points (30-48%) moderate disability.
- 25-34points (50- 64%) severe disability.
- 35-50points (70-100%) complete disability.
Measured: at baseline and after 4 weeks from the baseline.
Change in cervical range of motion (ROM) in sagittal, coronal and transverse planes from baseline to 4 weeks after.
AcuAngle® Inclinometer: (Baseline® AcuAngle Inclinometer; Elmsford, NY, U.S. PAT 2194335, 2-D Functions)
Measured: at baseline and after 4 weeks from the baseline.
Change in pain threshold from baseline to 4 weeks after.
Pain Pressure Algometer: (BASELINE 22-POUND DOLORIMETER).
Measured: at baseline and after 4 weeks from the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Aug 2022
- Primary completion30 Dec 2022
- Study completion1 Feb 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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haneen Mohamed Abo El-enen Ghalwash, Delta University for Science and Technology
- Investigators
- Haneen M. Ghalwash, Principal investigator, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730426
- Sponsor's protocol ID
- P.T.REC/012/003913
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2023
- Last updated
- 15 Feb 2023
- 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Dry Needling Versus Muscle Energy Technique on Chronic Non-specific Neck Pain; a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05730426
- Acronym / sponsor ID
- P.T.REC/012/003913
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 15 Feb 2023 (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 compare between applying deep dry needling and muscle energy technique in chronic non-specific neck pain patients. Researchers will compare between deep dry needling group, muscle energy technique group and control group to see if there are change in pain, range of motion or function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Deep dry needlingIn addition to Transcutaneous Electrical Nerve Stimulation (TENS) (typical,100 Hz, 20 mins), Infrared (7 mins), and Exercises (Cervical Stability Exercises through activation of deep neck flexors), patients received deep dry needling on active trigger points in selected muscles (upper trapezius, levator scapulae, and sternocleidomastoid ), 3 sessions/week, for 4 weeks period. |
| Group B | Active comparator | Procedure: Muscle energy techniqueIn addition to Transcutaneous Electrical Nerve Stimulation (TENS) (typical,100 Hz, 20 mins), Infrared (7 mins), and Exercises (Cervical Stability Exercises through activation of deep neck flexors), patients received muscle energy technique (post isometric relaxation) in selected muscles (upper trapezius, levator scapulae, and sternocleidomastoid ), 3 sessions/week, for 4 weeks period. |
| Group C | Placebo comparator | Procedure: Neck stability exercisePatients receive Transcutaneous Electrical Nerve Stimulation (TENS) (typical,100 Hz, 20 mins), Infrared (7 mins), and Exercises (Cervical Stability Exercises through activation of deep neck flexors) , 3 sessions/week, for 4 weeks period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 and 40 years.
- Current neck pain.
- Presence of at least one or two trigger points .
- Patients are diagnosed and referred from orthopedist complaining from chronic neck pain for at least 12 weeks.
- No clinical treatment for neck pain within the past month.
Key exclusion criteria (11 listed)
- Patients outside the target range.
- Neck pain associated with vertigo.
- Osteoporosis.
- Diagnosed psychological disorders.
- Fibromyalgia syndrome.
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 |
|---|---|---|
| Deep dry needlingMethod to decrease pain and improve function in musculoskeletal disorders. | Procedure or surgery | Group A |
| Muscle energy techniqueAlso: Post isometric relaxationMethod to decrease pain and improve function in musculoskeletal disorders. | Procedure or surgery | Group B |
| Neck stability exerciseMethod to decrease pain and improve function in musculoskeletal disorders. | Procedure or surgery | Group C |
Primary outcome
Change in pain intensity from baseline to 4 weeks after.
Time frame: at baseline and after 4 weeks from the baseline.
Visual Analogue scale (VAS) * A value of 0 denotes no pain, whereas a value of 1 to 3 indicates mild pain. * 4 to 6 denotes moderate pain. * 7 to 10 denotes intense pain.
Change in function from baseline to 4 weeks after.
Time frame: at baseline and after 4 weeks from the baseline.
The Neck Disability Index (NDI) The NDI questionnaire (scored out of 50) was used to measure the patient's perceived disability resulting from their neck pain. The score for each section was from 0 to 5, with 0 represented the highest level of function and 5 represented the lowest level of function. Total NDI scores were shown as a percentage. A high score corresponded to a higher degree of disability. * 0-4points (0-8%) no disability. * 5-14points (10 - 28%) mild disability. * 15-24points (30-48%) moderate disability. * 25-34points (50- 64%) severe disability. * 35-50points (70-100%) complete disability.
Change in cervical range of motion (ROM) in sagittal, coronal and transverse planes from baseline to 4 weeks after.
Time frame: at baseline and after 4 weeks from the baseline.
AcuAngle® Inclinometer: (Baseline® AcuAngle Inclinometer; Elmsford, NY, U.S. PAT 2194335, 2-D Functions)
Change in pain threshold from baseline to 4 weeks after.
Time frame: at baseline and after 4 weeks from the baseline.
Pain Pressure Algometer: (BASELINE 22-POUND DOLORIMETER).
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 Feb 2023.
- 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.
Haneen M. Ghalwash principal investigator
Delta University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep dry needling, Muscle energy technique and Neck stability exercise in people with Neck Pain, run by Cairo 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 7 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 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Change in pain intensity from baseline to 4 weeks after. (time frame: at baseline and after 4 weeks from the baseline.). 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 Feb 2023.