Chronic Neck PainNCT07663617
Effect of Mechanical Traction in Patients With Chronic Neck Pain
A study testing mechanical traction and conventional physical therapy in people with Chronic Neck Pain, run by Amira saad mohamed at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of mechanical traction on pain, disability, cervical range of motion, sleep quality and insomnia in patients with chronic neck pain. Forty four female patients with chronic neck pain will participate in this study. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- mechanical traction and conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female Patients with chronic neck pain.
- The age of patients will be ranged from 30-45 years old.
- Duration of pain will be more than six months.
Who cannot join
- Other neurological disorders causing sleep disorders as stroke and multiple sclerosis.
- Pregnancy.
- History of cervical spine surgery.
- Psychological disorders such as severe depression or anxiety.
- Active infection or malignancy in the cervical spine.
- Body mass index more than 30kg/m2.
- Diabetic or peripheral neuropathy.
- Severe myelopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mechanical Traction on Functional Outcome and Sleep Quality in Patients With Chronic Neck Pain
This study will be conducted to investigate the effect of mechanical traction on pain, disability, cervical range of motion, sleep quality and insomnia in patients with chronic neck pain. Forty four female patients with chronic neck pain will participate in this study. The patients will be diagnosed as having chronic neck pain based on careful clinical examination by neurologist. Patients in this study will be randomly divided into two equal groups:
Group (A): Patients in this group will receive mechanical traction for 20 minutes in addition to conventional physical therapy.
Group (B): Patients in this group will receive conventional physical therapy only. The treatment will be conducted over six weeks, three days per week.
- Conditions
- Chronic Neck Pain
- Being tested
- mechanical traction, conventional physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical tractionDevice
Participants will be positioned in supine on a flat bed. A manual traction test will be performed to ensure that traction did not provoke any pain or unwanted sensations.The mechanical traction will be applied at 45° from the horizontal plane formed by the bed
Mechanical traction was set to 5% of the participant's body weight on day 1 (unless not tolerated) and increased to reach 10% on the 5th day, as pain allowed, and without exceeding 12kg. Within a session, the load will applied progressively over 5 minutes and pain will be monitored using a VAS. The target weight will be then maintained for 20 minutes and then reduced gradually over the last 5 minutes. The patient then will lie still for 10 minutes before getting up
Patients recieved conventional physical therapy treatment in addition to mechanical traction conducted over six weeks, three days per week.
conventional physical therapyDevice
Patients recieved conventional physical therapy which will include:
1-10 minute hot packs on the cervical and upper back. 2- Ultrasound: It will be applied to paraspinal muscles with a frequency of 1 MHz with a continuous mode and 0.5 W/Cm2 for 5 minutes using moving sound head technique.
3- Transcutaneous electrical nerve stimulation: The electrodes will be placed at the level of cervical paraspinal muscles and at the course of affected nerve. The impulse duration will be adjusted to 1ms with an interval of 5 ms. and frequency of 166 Hz for 20 minutes The treatment will be conducted over six weeks, three days per week.
| Study group | Role | What they receive |
|---|---|---|
| Group A (exprimental) | Experimental | Patients in this group will receive mechanical traction for 20 minutes in addition to conventional physical therapy. The treatment will be conducted over six weeks, three days per week. Receives: Device: mechanical traction; Device: conventional physical therapy |
| Group B(control) | Active comparator | Patients in this group will receive conventional physical therapy only. The treatment will be conducted over six weeks, three days per week. Receives: Device: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
The visual analog scale (VAS) is frequently used to measure pain intensity in patients with cervical spine disorders. The minimum clinically important difference (MCID) is the smallest change in a score that has clinical importance to the patient. Although it has been established for other medical fields, knowledge of the VAS MCID for the cervical spine is sparse, and it has rarely been considered in relation to measurement noise. the score represented in numbers from 0 to 10.
Measured: pre intervention and re assessed after 6 weeks of treatment
neck disability
neck disability index questionnaire was used to assess the disability caused by neck pain. The Neck disability index is a commonly used method to determine functional disability level of subjects with neck pain. it is a 10-item questionnaire used to measure self-reported disability related to neck pain, with higher scores indicating greater functional limitation, Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total raw score ranges from 0 to 50, which can be converted to a percentage by doubling the score, giving a range from 0% (no disability) to 100% (complete disability),
Measured: pre intervention and re assessed after 6 weeks of treatment
Cervical Range of Motion (CROM)
Cervical Range of Motion (CROM) device. The CROM device is a type of goniometer designed specifically for the cervical spine and was used to measure cervical ROM. It consists of a plastic frame that is mounted over the subject's nose bridge and ears and secured to the head by a felcro strap. Three independent inclinometers attached to the frame and arranged orthogonally to one another indicate the subject's cervical ROM. Cervical Range of Motion (CROM) is measured in angles
Measured: pre intervention and re assessed after 6 weeks of treatment
sleep quality
Pittsburg Sleep Quality Index (PSQI) is used to assess sleep quality. The Pittsburg sleep quality index is a self administered questionnaire used to assess sleep quality. It is considered the gold standard for evaluating sleep quality over a period of 1 month. It consists of 19 items and were calculated as the following 7 components: sleep latency, sleep duration, sleep quality, sleep disturbances, sleep efficiency, sleep medication, and daytime dysfunction. Each component of them was weighted equally and scored on a scale from 0-3 for a total score from 0-21. Its validity is confirmed by various studies in different populations of patients
Measured: pre intervention and re assessed after 6 weeks of treatment
Insomnia Severity
The Insomnia Severity Index (ISI) is used to assess insomnia. Itis a seven-question questionnaire that is given to the respondent to assess recent problems with falling asleep, maintaining sleep, early awakening and the consequences of insomnia, using five-level points (from 0-none to 4-very, a lot). The ISI score is obtained by summing the points for each item, and it ranges from 0 to 28. Higher scores correspond to insomnia of greater intensity, and can be classified into four categories: no insomnia (0-7), borderline insomnia (8-14), clinically clear insomnia-moderately severe (15-21) and clinically clear insomnia-severe (22-28)
Measured: pre intervention and re assessed after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start20 Apr 2026
- Primary completion25 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amira saad mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira saad mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663617
- Sponsor's protocol ID
- 012/006273
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Traction on Functional Outcome and Sleep Quality in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT07663617
- Acronym / sponsor ID
- 012/006273
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Amira saad mohamedUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 23 Jun 2026 (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.
This study will be conducted to investigate the effect of mechanical traction on pain, disability, cervical range of motion, sleep quality and insomnia in patients with chronic neck pain. Forty four female patients with chronic neck pain will participate in this study. The patients will be diagnosed as having chronic neck pain based on careful clinical examination by neurologist. Patients in this study will be randomly divided into two equal groups:
Group (A): Patients in this group will receive mechanical traction for 20 minutes in addition to conventional physical therapy.
Group (B): Patients in this group will receive conventional physical therapy only. The treatment will be conducted over six weeks, three days per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (exprimental) | Experimental | Device: mechanical traction, Device: conventional physical therapyPatients in this group will receive mechanical traction for 20 minutes in addition to conventional physical therapy. The treatment will be conducted over six weeks, three days per week. |
| Group B(control) | Active comparator | Device: conventional physical therapyPatients in this group will receive conventional physical therapy only. The treatment will be conducted over six weeks, three days per week. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female Patients with chronic neck pain.
- The age of patients will be ranged from 30-45 years old.
- Duration of pain will be more than six months.
Key exclusion criteria (8 listed)
- Other neurological disorders causing sleep disorders as stroke and multiple sclerosis.
- Pregnancy.
- History of cervical spine surgery.
- Psychological disorders such as severe depression or anxiety.
- Active infection or malignancy in the cervical spine.
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 |
|---|---|---|
| mechanical tractionParticipants will be positioned in supine on a flat bed. A manual traction test will be performed to ensure that traction did not provoke any pain or unwanted sensations.The mechanical traction will be applied at 45° from the horizontal plane formed by the bed Mechanical traction was set to 5% of the participant's body weight on day 1 (unless not tolerated) and increased to reach 10% on the 5th day, as pain allowed, and without exceeding 12kg. Within a session, the load will applied progressively over 5 minutes and pain will be monitored using a VAS. The target weight will be then maintained for 20 minutes and then reduced gradually over the last 5 minutes. The patient then will lie still for 10 minutes before getting up Patients recieved conventional physical therapy treatment in addition to mechanical traction conducted over six weeks, three days per week. | Device | Group A (exprimental) |
| conventional physical therapyPatients recieved conventional physical therapy which will include: 1-10 minute hot packs on the cervical and upper back. 2- Ultrasound: It will be applied to paraspinal muscles with a frequency of 1 MHz with a continuous mode and 0.5 W/Cm2 for 5 minutes using moving sound head technique. 3- Transcutaneous electrical nerve stimulation: The electrodes will be placed at the level of cervical paraspinal muscles and at the course of affected nerve. The impulse duration will be adjusted to 1ms with an interval of 5 ms. and frequency of 166 Hz for 20 minutes The treatment will be conducted over six weeks, three days per week. | Device | Group A (exprimental), Group B(control) |
Primary outcome
pain intensity
Time frame: pre intervention and re assessed after 6 weeks of treatment
The visual analog scale (VAS) is frequently used to measure pain intensity in patients with cervical spine disorders. The minimum clinically important difference (MCID) is the smallest change in a score that has clinical importance to the patient. Although it has been established for other medical fields, knowledge of the VAS MCID for the cervical spine is sparse, and it has rarely been considered in relation to measurement noise. the score represented in numbers from 0 to 10.
neck disability
Time frame: pre intervention and re assessed after 6 weeks of treatment
neck disability index questionnaire was used to assess the disability caused by neck pain. The Neck disability index is a commonly used method to determine functional disability level of subjects with neck pain. it is a 10-item questionnaire used to measure self-reported disability related to neck pain, with higher scores indicating greater functional limitation, Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total raw score ranges from 0 to 50, which can be converted to a percentage by doubling the score, giving a range from 0% (no disability) to 100% (complete disability),
Cervical Range of Motion (CROM)
Time frame: pre intervention and re assessed after 6 weeks of treatment
Cervical Range of Motion (CROM) device. The CROM device is a type of goniometer designed specifically for the cervical spine and was used to measure cervical ROM. It consists of a plastic frame that is mounted over the subject's nose bridge and ears and secured to the head by a felcro strap. Three independent inclinometers attached to the frame and arranged orthogonally to one another indicate the subject's cervical ROM. Cervical Range of Motion (CROM) is measured in angles
sleep quality
Time frame: pre intervention and re assessed after 6 weeks of treatment
Pittsburg Sleep Quality Index (PSQI) is used to assess sleep quality. The Pittsburg sleep quality index is a self administered questionnaire used to assess sleep quality. It is considered the gold standard for evaluating sleep quality over a period of 1 month. It consists of 19 items and were calculated as the following 7 components: sleep latency, sleep duration, sleep quality, sleep disturbances, sleep efficiency, sleep medication, and daytime dysfunction. Each component of them was weighted equally and scored on a scale from 0-3 for a total score from 0-21. Its validity is confirmed by various studies in different populations of patients
Insomnia Severity
Time frame: pre intervention and re assessed after 6 weeks of treatment
The Insomnia Severity Index (ISI) is used to assess insomnia. Itis a seven-question questionnaire that is given to the respondent to assess recent problems with falling asleep, maintaining sleep, early awakening and the consequences of insomnia, using five-level points (from 0-none to 4-very, a lot). The ISI score is obtained by summing the points for each item, and it ranges from 0 to 28. Higher scores correspond to insomnia of greater intensity, and can be classified into four categories: no insomnia (0-7), borderline insomnia (8-14), clinically clear insomnia-moderately severe (15-21) and clinically clear insomnia-severe (22-28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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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 mechanical traction and conventional physical therapy in people with Chronic Neck Pain, run by Amira saad mohamed 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 3 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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: pre intervention and re assessed after 6 weeks of treatment). The study lists 5 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 23 Jun 2026.