Effects of Cranio-cervical Flexion on Cervical Proprioception
1 other identifier
interventional
30
1 country
1
Brief Summary
To determine the effects of cranio-cervical flexion training on the cervical proprioception and pain in patients with mechanical neck pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2021
CompletedFirst Posted
Study publicly available on registry
October 12, 2021
CompletedStudy Start
First participant enrolled
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2022
CompletedMarch 23, 2022
March 1, 2022
4 months
September 29, 2021
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cervical Range of Motion
The unit of CROM has three inclinometers attached to it and each inclinometer collects degree of movement in each plane.. One the CROM device is mounted on the patient's head, instructions are given to the patient regarding their neutral head movements and target head movements which are Right and Left sided rotation, Right and Left sided lateral flexion and cervical flexion and extension. After that, patient is blindfolded and all the movements are performed with patient being blindfolded. No feedback should be given during the ongoing session. This entire procedure takes around 15 minutes for one individual.
3 weeks
Secondary Outcomes (1)
Numeric Pain Rating Scale
3 weeks
Study Arms (2)
Cranio-Cervical Flexion Training Group
EXPERIMENTALParticipants of this group will receive conventional training along with cranio-cervical flexion training and home plan. Cranio-cervical flexion training will be given with the help of pressure biofeedback unit. the cuff will be inflated at a specific pressure level and patient will be asked to maintain that pressure and gradually increase it.
Conventional Therapy Group
ACTIVE COMPARATORParticipants of this group will receive only conventional therapy and home plan will be given which includes; hot pack, TENS, neck isometrics and passive stretching of neck musculature. Home plan will include self-stretches and neck isometrics.
Interventions
Participants of this group will receive conventional training along with Cranio-cervical flexion training: * The pressure cuff is placed behind the neck just next to the occiput and inflated up to a baseline pressure of 20 mmHg. The patient is asked to perform Cranio-Cervical Flexion (CCF) to sequentially reach 5 pressure targets in 2 mmHg increments from a baseline of 20 mmHg to the final level of 30 mmHg. For each target level, the patient is instructed to maintain the contraction for 10 sec for 10 repetitions with brief rest periods between each contraction i.e., 3-5 seconds. Once a set of 10 repetitions of 10 sec is achieved at one target level, the exercise is progressed to train at the next target level up to the final target level at 30 mmHg. Conventional therapy will be given along with home plan. Exercise protocol will consist of 30 minutes. Exercise will have total 3 sessions/week for 3 weeks.
Participants of this group will receive only conventional therapy and home plan will be given which includes; * Hot pack placed on the posterior neck for 15 minutes. * Transcutaneous electrical nerve stimulation (TENS) with a frequency of 80 Hz for 20 minutes with 10-30 mA intensity. * Isometric exercises: Isometric neck flexion, extension, side bending exercises. 10 repetitions. Hold period is 10 seconds for each movement. Resistance would be provided manually by the therapist. * Stretching exercises: Passive stretching for Sternocleidomastoid, Trapezius, Pectoralis Major. 10 reps and each stretch maintained for 10 seconds. * Home Plan: Patients will be given a home plan of self-stretches and isometrics and instructions on how to perform and number of repetitions will be guided. Exercise protocol will consist of 25 minutes. Exercise will consist of total 3 sessions/week for 3 weeks
Eligibility Criteria
You may qualify if:
- Patients with mechanical neck pain with minimum duration of 4 weeks,
- Pain in the cervical region with moving or palpating the cervical spine,
- upper cervical involvement with or without headache and C1-C2 rotational deficits.
You may not qualify if:
- Vertebrobasilar insufficiency.
- Any history of serious underlying pathology, cervical trauma, structural deformities, genetic spinal disorders or previous spinal surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SPIRE Medical Mall
Islamabad, Punjab Province, 45720, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saad Rauf, Master
Riphah International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2021
First Posted
October 12, 2021
Study Start
November 2, 2021
Primary Completion
February 17, 2022
Study Completion
February 17, 2022
Last Updated
March 23, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share