“Effectiveness of Deep Cervical Fascial manipulation and Yoga postures on pain, function and oculomotor control in mechanical neck pain: A pragmatic, parallel group, randomized, controlled trialâ€
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- •Numeric pain rating scale (NPRS).
Study Overview
Brief Summary
Purpose: The pathological modifications of deep fascia are considered to be one of the sources of musculoskeletal pain. Mechanical Neck pain (MNP) is usually treated symptomatically and the involvement of the deep cervical fascia (DCF) and its continuum is often ignored which may be involved in the presence of plethora of symptoms.The associated symptoms of the upper quarter with MNP, leads to an extensive treatment without any positive treatment effect. This mandates the need for treatment, focusing on the anatomical myofascial continuum (DCF and its continuum) of the upper quarter which may help in relieving MNP. There is a dearth of literature on the anatomical continuity of deep cervical fascia and their potential implications in patients with MNP. A well-designed pragmatic study investigating the role of deep fascia and incorporating manipulation of the fascia in MNP is needed. Aim of the study: To study the effectiveness of deep cervical fascial manipulation and it’s continuum on pain, patient-specific functions, oculomotor control, and myofascial stiffness in sub-acute and chronic mechanical neck pain. Primary objective: To study the effectiveness of fascia directed approach that includes fascial manipulation (4 sessions in 3-4 weeks) and sequential yoga poses (12 weeks) as compared to usual care. The objective is to study effects on function, oculomotor control and pain in patients with subacute and chronic mechanical neck pain. Primary research hypothesis Secondary objectives 1. To study the effectiveness of fascia directed treatment approaches (FM & SYP), in comparison to usual care on elbow extension ROM angle during ULNT 2. To examine the modifying effects on the viscoelastic properties (tone, stiffness, elasticity) of myofascia by combining FM and SYP, compared to usual care in patients with MNP. 3. To investigate if there is any change in the patient-reported fear avoidance behavior with interventions such as FM and SYP when compared with the routine treatment of patients with MNP. The hypothesis of this study is fascia directed treatment approaches (FM and SYP) will be better to usual care (Therapeutic exercises, mobilisation, manipulation) for improving pain, functions and oculomotor control in subjects with MNP.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Participants: Patients with sub-acute and chronic mechanical neck pain for more than 3 weeks. Study setting Outpatient clinics at Kasturba hospital and its allied centres (Recruitment) Department of Exercise and sports sciences.
- •Centre for sports science, medicine and research (Interventions and Outcome measures) Outpatient clinic.
- •Department of Speech and Hearing (Outcome measures).
Exclusion Criteria
- •History of trauma to the upper quarter region in the last one year.
- •Diagnosed diabetic neuropathy 3) Vestibular balance disorders 4) Medical conditions (speech and hearing and visual disorders) 5) Any previous surgical interventions to the upper quarter in last 1 year.
- •Diagnosed bony lesions/ systemic diseases/ cancer 7) Systemic inflammatory diseases like rheumatoid arthritis.
- •Infections and Skin lesions localized to the symptomatic head, neck and upper limb.
- ••Signs of neurological involvement such as positive ULNT, positive spurlings test, diminished sensation and reflexes, as well as strength deficits at the nerve root level of C5 to T
- •Any signs suggestive of myelopathy 10) Pregnant women.
Outcomes
Primary Outcomes
•Numeric pain rating scale (NPRS).
Time Frame: NPRS- Baseline,1st,2nd, 3rd 4th week, 3rd month and 6th month following 1st intervention | PSFS: Baseline,4th week, 3rd month and 6th month following 1st intervention | Oculomotor Control: Baseline,4th week, 3rd month following 1st intervention
•Patient specific functional scale (PSFS)
Time Frame: NPRS- Baseline,1st,2nd, 3rd 4th week, 3rd month and 6th month following 1st intervention | PSFS: Baseline,4th week, 3rd month and 6th month following 1st intervention | Oculomotor Control: Baseline,4th week, 3rd month following 1st intervention
•Oculomotor control tests
Time Frame: NPRS- Baseline,1st,2nd, 3rd 4th week, 3rd month and 6th month following 1st intervention | PSFS: Baseline,4th week, 3rd month and 6th month following 1st intervention | Oculomotor Control: Baseline,4th week, 3rd month following 1st intervention
Smooth pursuit neck torsion test, saccades using Videonystagmography
Time Frame: NPRS- Baseline,1st,2nd, 3rd 4th week, 3rd month and 6th month following 1st intervention | PSFS: Baseline,4th week, 3rd month and 6th month following 1st intervention | Oculomotor Control: Baseline,4th week, 3rd month following 1st intervention
Near point convergence (NPC) test using RAF ruler
Time Frame: NPRS- Baseline,1st,2nd, 3rd 4th week, 3rd month and 6th month following 1st intervention | PSFS: Baseline,4th week, 3rd month and 6th month following 1st intervention | Oculomotor Control: Baseline,4th week, 3rd month following 1st intervention
Secondary Outcomes
- Myofascial stiffness,(Elbow extension range of motion(EEROM) during upper limb neurodynamics test 1)
