Disc HerniationNCT05803954

Mobilization With Movement vs. Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy

A study testing Sustained natural apophyseal glides (SNAGS), Neural mobilization and Traditional physical therapy in people with Disc Herniation and Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will be conducted to compare the effect of sustained natural apophyseal glides (SNAGS) versus neural mobilization on clinical outcomes such as 1- nerve root function in the form of: (A) peak to peak amplitude; (B) latency; (C) F wave. Read more about this study

Who is it for?: Ages 20 to 50 years
Conditions the study is for: Disc Herniation, Cervical Radiculopathy, Cervical Radiculopathy at C5 Nerve Root
What is being tested?: Sustained natural apophyseal glides (SNAGS), Neural mobilization and Traditional physical therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteEgypt
Study dates: 31 Mar 2023to 1 Jul 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 20 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

seventy patients with cervical disc (C 5-C 6 and/or C 6- C7) herniation with both sensory and motor nerve affections, referred from neurologist and confirmed diagnosis by MRI
Both sexes.
Age between 20-50 years.
Patients with neck pain radiating down to the arm.
Patients with positive findings for spurling test, Upper Limb Tension Test One (ULTTO), cervical distraction test and cervical rotation test towards the symptomatic side <60.
BMI from 18 to 25 kg/cm2
Existed active trigger points within middle trapezius and/ or cervical region.
Positive Pittsburgh sleep quality index' value >10, means moderate and/ or sever difficulty.

Who cannot join

Patients experiencing primary shoulder or upper extremity problem of local origin
cardiovascular disorders and respiratory disorders,
pathological conditions involving cervical spine like vertebro basilar insufficiency and canal stenosis
osteophytes in cervical vertebrae
Patients who were undergoing treatment for neck pain with other means of physiotherapy at the time of the study
Cervical fractures, spinal surgery or other spinal pathologies (i.e. ankylosing spondylitis, spondylolisthesis)
Peripheral nerve lesions like neurotmesis and axonotmesis.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ismailia medical complex
Ismailia

Other trials in Egypt

About this study

Official title: Mulligan Mobilization Technique Versus Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy: Randomized Controlled Trial

Seventy two patients from both gender with cervical disc (C 5-C 6 and/or C 6- C7) herniation with both sensory and motor nerve affections will be recruited for this study following referral from an experienced neurologist and confirmed diagnosis by MRI. The patients' age will range between 20-50 years, body mass index (BMI) from 18 to 25 kg/cm2.

The patients will be assigned randomly by permuted block to three equal groups; group (A) will receive SNAGS in addition to traditional therapy, group (B) will receive neural mobilization in addition to traditional therapy and group (C) will receive traditional therapy.

peak to peak amplitude, nerve latency and F wave will be measured by electromyography, , pressure pain threshold will be measured by commander algometer. Neck disability will be measured by Arabic neck disability index.

Conditions: Disc Herniation, Cervical Radiculopathy, Cervical Radiculopathy at C5 Nerve Root, Cervical Radiculopathy at C6 Nerve Root, Cervical Radiculopathy at C7 Nerve Root
Being tested: Sustained natural apophyseal glides (SNAGS), Neural mobilization, Traditional physical therapy
Medical subject headings: Intervertebral Disc Displacement, Radiculopathy

What participants receive

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

Sustained natural apophyseal glides (SNAGS)Other
SNAGS will be applied with the patient sitting comfortably on a stool. The therapist stand behind the patient and the medial border of one thumb's distal phalanx is placed on the articular pillar on the chosen side of the suspected site of lesion. The thumb nail slope at approximately 45 degree (in the direction of the eyeball). SNAGS mulligan will be given by active movement followed by passive overpressure based on the movement restricted by frequency of treatment will be three sets of ten repetitions. SNAG the anteroposterior mobilization of the second cervical vertebrae is sustained for 10 to 30 s depending on response. A maximum of 6 repetitions will be given if there is a reduction in headache intensity at the time of the first application. A total of 20 oscillations (1 oscillation/1 second) will be given to each joint with a total duration of 15 minutes
Neural mobilizationOther
Neural mobilization will be applied with grade three neural mobilization and traditional therapy: Subjects will be placed in supine position and remained relaxed with the feet uncrossed. The patient will be slightly angled obliquely for easier access to the scapula. The therapist will be depressed the scapula with concomitant upper extremity joint positioning as per median nerve bias i.e., ULTT2 (shoulder abduction, elbow extension with forearm supination, wrist and fingers extended and ulnar deviated and thumb abduction). The wrist will be used as a tension factor and at the point where tension was felt by the therapist and perceived by the subject. Grade 3 oscillations were given rhythmically and slowly to each joint from proximal to distal. A total of 20 oscillations (1 oscillation/1 second) were given to each joint with a total duration of 15 minutes.
Traditional physical therapyOther
traditional therapy will be applied in the form of stretching for bilateral upper and middle trapezius muscles and bilateral neck rotators and isometric strengthening exercises for neck rotators, extensors, side bending muscles. Exercise was repeated for ten repetitions per session. In addition to hot pack was placed over the neck and upper part of shoulders musculature. This was being applied for ten min, over middle trapezius trigger Point itself.

Study groups in NCT05803954
Study group	Role	What they receive
Group A (SNAGs group)	Experimental	Not described Receives: Other: Sustained natural apophyseal glides (SNAGS); Other: Traditional physical therapy
Group B (Neural mobilization group)	Experimental	Not described Receives: Other: Neural mobilization; Other: Traditional physical therapy
Group C (traditional physical therapy)	Active comparator	Not described Receives: Other: Traditional physical therapy

What is being measured

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

F-wave parameters
Evaluation of the spinal motoneuron excitability through the measurement of the F wave parameters
Measured: Change over the course of the study, from baseline to the end of treatment program at 4 weeks
Somatosensory Evoked Potentials (SEPs) Latency and Amplitude
SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli. SEPs are read on the skull with electroencephalography (EEG)
Measured: Change over the course of the study, from baseline to the end of treatment program at 4 weeks
Pain pressure threshold by Pressure algometer
An algometer will be used used to quantify pain intensity by pressure
Measured: Change over the course of the study, from baseline to the end of treatment program at 4 weeks

Secondary outcomes (1)

Neck disability Index
Methods of assessment for such disability, especially those targeted at activities of daily living which are most affected by neck pain, questionnaire 10-item scaled entitled the Neck Disability Index (NDI)
Measured: Change over the course of the study, from baseline to the end of treatment program at 4 weeks

Timeline

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

31 Mar 20231 Jul 2023

First posted7 Apr 2023
Study start31 Mar 2023
Primary completion1 Jul 2023
Study completion1 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Disc HerniationStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05803954
Sponsor's protocol ID: MMNM2023
Status last verified: Jul 2023
First submitted: 25 Mar 2023
Last updated: 6 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Disc Herniation trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mulligan Mobilization Technique Versus Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy: Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05803954
Acronym / sponsor ID: MMNM2023
Conditions: Disc Herniation, Cervical Radiculopathy, Cervical Radiculopathy at C5 Nerve Root, Cervical Radiculopathy at C6 Nerve Root, Cervical Radiculopathy at C7 Nerve Root
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 31 Mar 2023 (actual)
Primary completion: 1 Jul 2023 (actual)
Study completion: 1 Jul 2023 (actual)
First posted: 7 Apr 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group A (SNAGs group)	Experimental	Other: Sustained natural apophyseal glides (SNAGS), Other: Traditional physical therapy
Group B (Neural mobilization group)	Experimental	Other: Neural mobilization, Other: Traditional physical therapy
Group C (traditional physical therapy)	Active comparator	Other: Traditional physical therapy

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

seventy patients with cervical disc (C 5-C 6 and/or C 6- C7) herniation with both sensory and motor nerve affections, referred from neurologist and confirmed diagnosis by MRI
Both sexes.
Age between 20-50 years.
Patients with neck pain radiating down to the arm.
Patients with positive findings for spurling test, Upper Limb Tension Test One (ULTTO), cervical distraction test and cervical rotation test towards the symptomatic side <60.

Key exclusion criteria (7 listed)

Patients experiencing primary shoulder or upper extremity problem of local origin
cardiovascular disorders and respiratory disorders,
pathological conditions involving cervical spine like vertebro basilar insufficiency and canal stenosis
osteophytes in cervical vertebrae
Patients who were undergoing treatment for neck pain with other means of physiotherapy at the time of the study

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
Sustained natural apophyseal glides (SNAGS)SNAGS will be applied with the patient sitting comfortably on a stool. The therapist stand behind the patient and the medial border of one thumb's distal phalanx is placed on the articular pillar on the chosen side of the suspected site of lesion. The thumb nail slope at approximately 45 degree (in the direction of the eyeball). SNAGS mulligan will be given by active movement followed by passive overpressure based on the movement restricted by frequency of treatment will be three sets of ten repetitions. SNAG the anteroposterior mobilization of the second cervical vertebrae is sustained for 10 to 30 s depending on response. A maximum of 6 repetitions will be given if there is a reduction in headache intensity at the time of the first application. A total of 20 oscillations (1 oscillation/1 second) will be given to each joint with a total duration of 15 minutes	Other	Group A (SNAGs group)
Neural mobilizationNeural mobilization will be applied with grade three neural mobilization and traditional therapy: Subjects will be placed in supine position and remained relaxed with the feet uncrossed. The patient will be slightly angled obliquely for easier access to the scapula. The therapist will be depressed the scapula with concomitant upper extremity joint positioning as per median nerve bias i.e., ULTT2 (shoulder abduction, elbow extension with forearm supination, wrist and fingers extended and ulnar deviated and thumb abduction). The wrist will be used as a tension factor and at the point where tension was felt by the therapist and perceived by the subject. Grade 3 oscillations were given rhythmically and slowly to each joint from proximal to distal. A total of 20 oscillations (1 oscillation/1 second) were given to each joint with a total duration of 15 minutes.	Other	Group B (Neural mobilization group)
Traditional physical therapytraditional therapy will be applied in the form of stretching for bilateral upper and middle trapezius muscles and bilateral neck rotators and isometric strengthening exercises for neck rotators, extensors, side bending muscles. Exercise was repeated for ten repetitions per session. In addition to hot pack was placed over the neck and upper part of shoulders musculature. This was being applied for ten min, over middle trapezius trigger Point itself.	Other	Group A (SNAGs group), Group B (Neural mobilization group), Group C (traditional physical therapy)

Primary outcome

F-wave parameters
Time frame: Change over the course of the study, from baseline to the end of treatment program at 4 weeks
Evaluation of the spinal motoneuron excitability through the measurement of the F wave parameters
Somatosensory Evoked Potentials (SEPs) Latency and Amplitude
Time frame: Change over the course of the study, from baseline to the end of treatment program at 4 weeks
SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli. SEPs are read on the skull with electroencephalography (EEG)
Pain pressure threshold by Pressure algometer
Time frame: Change over the course of the study, from baseline to the end of treatment program at 4 weeks
An algometer will be used used to quantify pain intensity by pressure

1 secondary outcome

Neck disability Index
Time frame: Change over the course of the study, from baseline to the end of treatment program at 4 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 6 Jul 2023.
Individual participant dataSharing planned: No

Related trials for Disc Herniation

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Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Not yet recruiting
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Not yet recruiting
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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.

Amany I. Selem, BSc principal investigator

Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 7 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 6 Jul 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. 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?

F-wave parameters (time frame: Change over the course of the study, from baseline to the end of treatment program at 4 weeks). The study lists 3 primary outcomes in all. 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 NCT05803954.

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 6 Jul 2023.