Clinical trial NCT05803954: Mobilization With Movement vs. Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy
Official title: Mulligan Mobilization Technique Versus Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disc Herniation
Cervical Radiculopathy
Cervical Radiculopathy at C5 Nerve Root
Cervical Radiculopathy at C6 Nerve Root
Cervical Radiculopathy at C7 Nerve Root
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 2- pain pressure threshold (PPT) and 3- Neck disability index (NDI) in patients with cervical disc (C5-C6 and/or C6-C7) herniation.

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Both sexes.
3. Age between 20-50 years.
4. Patients with neck pain radiating down to the arm.
5. 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.
6. BMI from 18 to 25 kg/cm2
7. Existed active trigger points within middle trapezius and/ or cervical region.
8. Positive Pittsburgh sleep quality index' value \>10, means moderate and/ or sever difficulty.

Exclusion Criteria:

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

Primary outcomes:
measure: F-wave parameters
timeFrame: Change over the course of the study, from baseline to the end of treatment program at 4 weeks
measure: Somatosensory Evoked Potentials (SEPs) Latency and Amplitude
timeFrame: Change over the course of the study, from baseline to the end of treatment program at 4 weeks
measure: Pain pressure threshold by Pressure algometer
timeFrame: Change over the course of the study, from baseline to the end of treatment program at 4 weeks
Secondary outcomes:
measure: Neck disability Index
timeFrame: Change over the course of the study, from baseline to the end of treatment program at 4 weeks
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Ismailia medical complex
Study officials:
affiliation: Cairo University
name: Amany I. Selem, BSc
role: PRINCIPAL_INVESTIGATOR
References: