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Neck Pain, PosteriorNCT05428254

Radiofrequency Therapy for Chronic Neck Pain.

A study testing Capacitive and Resistive Radiofrequency therapy and Exercise therapy in people with Neck Pain, Posterior, run by Umm Al-Qura University at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Chronic neck pain (CNP) is a major health problem affecting individuals with high prevalence and subsequent complications which interfere with the physical, personnel, and psychological status. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Neck Pain, Posterior
What is being tested?
Capacitive and Resistive Radiofrequency therapy and Exercise therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSaudi Arabia
Study dates
Jul 2022to Dec 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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with chronic neck pain.
  • Age is above 18 years.
  • patients had chronic pain ≥ 3 months,
  • The radiological examination showed that the patients is free from any discogenic cause of pain.
  • Patients are willing to stop medications.
  • Patients accepted to assign informed consent to participate in the current study and will attend the lab twice a week for six successive weeks.

Who cannot join

  • They have any known significant medical conditions such as hypertension, asthma, cardiac disease, or systemic disease that adversely affect them during testing.
  • Previous neck surgery/injection for the last six months.
  • Previous vertebral fracture or malignancy.
  • Patients have a discogenic pain or any other radicular manifestation to the upper limb.
  • Unable to commit study requirements.

Trial locations and contacts

1 site in 1 country.

Mohamed S Alayat, Ph.D contact

+966566003665

mohsalahpt@hotmail.com

Mohamed Alayat, Ph.D contact

msayiat@uqu.edu.sa

Saudi Arabia1 site
  • Umm Al-Qura University, Faculty of Applied Medical Science

    Mecca, 21955

Other trials in Saudi Arabia

About this study

Official title: The Effectiveness of Capacitive and Resistive Radiofrequency Therapy Alone or With Manual Therapy in the Treatment of Patients With Chronic Non-specific Mechanical Neck Pain.

Background: Chronic neck pain (CNP) is a major health problem affecting individuals with high prevalence and subsequent complications which interfere with the physical, personnel, and psychological status. The capacitive and resistive radiofrequency therapy (CRRT) is a relatively new treatment modality used in rehabilitation with no evidence on its efficacy on chronic neck pain.

Objective: The aim of the present study is to investigate the effect of the CRRT alone or with manual therapy in the treatment of patients with patients with non-specific CNP.

Hypotheses Is the application of the CRRT when applied alone or with combination with manual therapy and exercises effective in decreasing pain and improving the function and strength in patients with non-specific chronic neck pain?? Methods: 60 patients will participle in the study. They will be recruited from the hospital in mecca, Saudi Arabia. They will be randomized into three groups. Group I will be treated with stretching exercises (EX) and manual therapy (Manual + EX group). Group II will be treated with CRRT plus exercises (CRRT+ EX group). Group III will be treated by EX plus manual therapy applied during CRRT for groups (Manual + CRRT+ EX group). For groups II and III, capacitive electrodes will be applied for five minutes. Then the resistive electrodes will be applied for 10 minutes and finally the capacitive will be applied again for another five minutes. Assessment of the neck pain, function, CROM, trigger points, neck muscle strength as well as neck angles will be performed. Measurement will be performed before, after 6 weeks, and 6 months of treatment as follow up measurements. Multivariate analysis of variance was used to compare between and within groups. The level of statistical significance is set as P<0.05.

Read the detailed description

Chronic neck pain (CNP) is a major health problem affecting individuals with high prevalence 90.4 to 86.8% of the population) and comes secondary to low back pain. It exerts negative pressure on personnel, their families, and health organizations in addition to the decreases of workdays and productivity loss. CNP may be associated with referred pain, restricted range of motion, headache, presence of trigger points, dysfunction of the cervical musculature and presence of faulty posture.

Rehabilitation of patients with CNP may include the mechanical, electrical and /or, thermal modalities which are applied with the manual techniques and exercise therapy. The capacitive and resistive radiofrequency therapy (CRRT) is a long-wave diathermy with a long-lasting thermal effect used to decrease pain and muscle spasm in case of lumbago, fibromyalgia, and knee osteoarthritis.

Literature comparing the efficacy of each modality with exercise or with manual therapy. Previous literature used CRRT for only its thermal effect. The CRRT may combine the effect of thermal, electrical, and mechanical modalities as well as the effect of exercise and manual therapy with a new technique not used previously. This study is the first study using CRRT with a new technique which combines the effect of the CRRT with the manual therapy to treat patients with CNP.

Objective of the project:

The aim of the present study is to investigate the effect of the CRRT in the treatment of patients with non-specific CNP. The CRRT will be applied to the posterior neck and shoulder areas for two sessions per week for six weeks. CRRT will be applied alone or combined with manual therapy and stretching exercises.

  1. To investigate the short-term effect of the CRRT on the neck pain, function, and cervical range of motion (ROM), the pressure pain threshold of the trigger points trapezius upper fibers, neck muscle strength, and the neck angles.
  2. Compare the effect of CRRT alone to the combined effect of CRRT and manual therapy on the measured outcomes.
  3. To investigate the long-term effect of CRRT alone or combined with manual therapy on patients with non-specific CNP.

Hypotheses Is the application of the CRRT when applied alone or in combination with manual therapy and exercises effective in decreasing pain and improving the function and strength in patients with non-specific chronic neck pain??

Ethical Approval:

this protocol had an ethical approval from the Institute Review Board of biomedical research ethics committee, Umm Al-Qura University Makkah, Saudi Arabia A written consent form also will be provided for all participants.

Being tested
Capacitive and Resistive Radiofrequency therapy, Exercise therapy
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capacitive and Resistive Radiofrequency therapyOther

    Also called Transfer Electrical Capacitive And Resistive (TECAR therapy)

    TECAR or CRRT is electromagnetic waves produced by high frequency electrical current that are able to penetrate very deep and produce a long-lasting heat which stimulates the superficial and dep tissues and produce a potent long-lasting pain-relieving effect. Mild intensity of heat produced by the long wave diathermy may be used to promote proliferation (Hernández-Bule et al., 2014) and improve the vascularization of skin and muscles.

    The integration of two operational modes, Capacitive (CAP) and Resistive (RES), makes it possible to combine sub-thermal (electric) and thermal effects. Indiba radiofrequency has output frequency: 448kHz ± 1 kHz with Maximum output power in RES mode: 100 W and in CAP mode: 350 VA. The capacitive used an isolated metal coated electrode acts as a dielectric surface which concentrate the electrical charges near the capacitive electrode While the resistive electrode causing the diffusion of electrical charges which accumulate near bone and soft tissues.

  • Exercise therapyOther

    Stretching of the neck extensor, upper fibers of trapezius, levator scapulae and scalenus muscles. stretching is applied for at least 15 seconds and repeated ten times in each session.

Study groups in NCT05428254
Study groupRoleWhat they receive
Exercise and Manual therapyActive comparatorGroup I will be treated with stretching exercises (EX), manual therapy (EX group) and serves as a control group. Stretching of the neck extensor, upper fibers of trapezius, levator scapulae and scalenus muscles. stretching is applied for at least 15 seconds and repeated ten times in each session. Mobilization of the facet joint of the cervical vertebrae is performed after neck exercises.
Receives: Other: Exercise therapy
Exercise and radiofrequency therapyActive comparatorGroup II will be treated with capacitive and resistive radiofrequency therapy plus EX without manual therapy (CRRT+ EX group). In addition to neck stretching exercises, they will receive 20 minutes of CRRT. Both the capacitive and resistive electrodes. CRRT is applied by the INDIBA radiofrequency therapy. INDIBA radiofrequency therapy has a long wavelength diathermy with frequency of 488 KHz range. The integration of two operational modes capacitive electrode (CAP) and (RES), makes it possible to combine sub-thermal (electric) and thermal effects. Indiba radiofrequency has output frequency: 448kHz ± 1 kHz with Maximum output power in RES mode: 100 W and in CAP mode: 350 VA. Capacitive electrodes will be applied for five minutes. Then the resistive electrodes will be applied for 10 minutes and finally the capacitive will be applied again for another five minutes.
Receives: Other: Capacitive and Resistive Radiofrequency therapy; Other: Exercise therapy
Exercise, Manual and Radiofrequency therapyActive comparatorPatients in this group will receive the same program of exercises as in group one. in addition, patients will receive the CRRT as in group two and the mobilization of the facet joints of the cervical vertebrae is applied while applied the CRRT by a trained physiotherapist. The same protocol of mobilization is applied for group one and three.
Receives: Other: Capacitive and Resistive Radiofrequency therapy; Other: Exercise therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity

    The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.

    Measured: Measurement will be performed before treatment.

  2. Pain intensity

    The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.

    Measured: Measurement will be performed after 6 weeks of treatment.

  3. Pain intensity

    The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.

    Measured: Measurement will be performed after 3 months of treatment as follow up measurement.

  4. Pain intensity

    The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line.

    Measured: Measurement will be performed after 6 months of treatment as follow up measurement.

Secondary outcomes (4)
  1. Neck disability index

    The level of function is measured by the neck disability index. An Arabic version of neck disability index (NDI) will be filled for all patients. NDI is the most frequently functional activity index used for neck related disabilities and is considered as a valid and reliable measure used in patients with neck pain. NDI is a self-perceived disability neck pain from. Every patient is asked to mark the in each section which most describes his level of disability. Each item is recorded out of 5 for a maximum total score of 50

    Measured: Measurement will be performed before treatment.

  2. Neck disability index

    The level of function is measured by the neck disability index. An Arabic version of neck disability index (NDI) will be filled for all patients. NDI is the most frequently functional activity index used for neck related disabilities and is considered as a valid and reliable measure used in patients with neck pain. NDI is a self-perceived disability neck pain from. Every patient is asked to mark the in each section which most describes his level of disability. Each item is recorded out of 5 for a maximum total score of 50

    Measured: Measurement will be performed after 6 weeks of treatment.

  3. Neck disability index

    The level of function is measured by the neck disability index. An Arabic version of neck disability index (NDI) will be filled for all patients. NDI is the most frequently functional activity index used for neck related disabilities and is considered as a valid and reliable measure used in patients with neck pain. NDI is a self-perceived disability neck pain from. Every patient is asked to mark the in each section which most describes his level of disability. Each item is recorded out of 5 for a maximum total score of 50

    Measured: Measurement will be performed after 3 months of treatment as a follow up measurement.

  4. Neck disability index

    The level of function is measured by the neck disability index. An Arabic version of neck disability index (NDI) will be filled for all patients. NDI is the most frequently functional activity index used for neck related disabilities and is considered as a valid and reliable measure used in patients with neck pain. NDI is a self-perceived disability neck pain from. Every patient is asked to mark the in each section which most describes his level of disability. Each item is recorded out of 5 for a maximum total score of 50

    Measured: Measurement will be performed after 6 months of treatment as a follow up measurement.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2022
  2. Study startJul 2022 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
A total of 60 patients will participle in the study. They will be recruited from the hospital in Mecca, Saudi Arabia. They will be randomized into three groups. Group I will be treated with stretching exercises (EX) and manual therapy (Manual + EX group). Group II will be treated with CRRT plus EX without manual therapy (CRRT+ EX group). Group III will be treated by EX plus manual therapy applied during CRRT for groups (Manual + CRRT+ EX group). For group II and III, capacitive electrodes will be applied for five minutes. Then the resistive electrodes will be applied for 10 minutes and finally the capacitive will be applied again for another five minutes.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05428254
Sponsor's protocol ID
22-MED-06-1111
Status last verified
Jun 2022
First submitted
12 Jun 2022
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Capacitive and Resistive Radiofrequency therapy and Exercise therapy in people with Neck Pain, Posterior, run by Umm Al-Qura University at 1 site in Saudi Arabia.

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 6 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: status not confirmed, as of the sponsor's last update on 23 Jun 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 Saudi Arabia. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed S Alayat, Ph.D (+966566003665, mohsalahpt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: Measurement will be performed before treatment.). 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 23 Jun 2022.

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