TY - JOUR
T1 - Effectiveness of deep cervical fascial manipulation and yoga postures on pain, function, and oculomotor control in patients with mechanical neck pain
T2 - study protocol of a pragmatic, parallel-group, randomized, controlled trial
AU - Raja G, Prabu
AU - Bhat N, Shyamasunder
AU - Fernández-de-las-Peñas, César
AU - Gangavelli, Ranganath
AU - Davis, Fiddy
AU - Shankar, Ravi
AU - Prabhu, Anupama
N1 - Funding Information:
The authors wish to acknowledge Mrs. Ashwini for her assistance in editing this manuscript. The principal investigator will obtain informed consent from the participants. If there are any modifications in the protocol, amendments will be communicated with the IEC. All information about the participants, including the paper forms as well as the electronic data, will be securely stored at the study site. Access to these data will be limited. Information about the study will not be released without the participant?s prior permission. No ancillary or post-trial care will be provided to the participants. Communicating trial result: The details of the interventions will be given to the participants if requested, so that trained therapists can replicate the treatment. Authorship eligibility: Committee on Publication Ethics (COPE) guidelines on good publication practice will be followed.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Introduction: Mechanical neck pain (MNP) is a commonly occurring musculoskeletal condition that is usually managed using electrical modalities, joint mobilization techniques, and therapeutic exercises, but has limited evidence of their efficacy. Pathology (densification) of the deep cervical fascia that occurs due to the increased viscosity of hyaluronic acid (HA) may induce neck pain and associated painful symptoms of the upper quarter region. Fascial manipulation (FM) and yoga poses are considered to reduce the thixotropy of the ground substances of the deep fascia and improve muscle function. The purpose of this study is to investigate the effect of FM and sequential yoga poses (SYP) when compared to the usual care on pain, function, and oculomotor control in MNP. Methods: This FaCe-Man trial will recruit 160 patients with subacute and chronic mechanical neck pain diagnosed using predefined criteria. Participants will be randomized to either the intervention group or the usual care group, using a random allocation ratio of 1:1. Patients in the intervention group will receive FM (4 sessions in 4 weeks) and SYP (12 weeks) whereas the standard care group will receive cervical mobilization/ thoracic manipulation (4 sessions in 4 weeks) and therapeutic exercises (12 weeks). The primary outcome is the change in the numeric pain rating scale (NPRS). The secondary outcomes include changes in the patient-specific functional scale and oculomotor control, myofascial stiffness, fear-avoidance behavior questionnaire, and elbow extension range of motion during neurodynamics test 1. Discussion: If found effective, FM along with SYP investigated in this trial can be considered as a treatment strategy in the management of mechanical neck pain. Considering the magnitude of the problem, and the pragmatic and patient-centered approach to be followed, it is worth investigating this trial. Trial registration: ClinicalTrials.gov CTRI/2020/01/022934. Registered on January 24, 2020 with ctri.nic.in. Clinical Trials Registry – India.
AB - Introduction: Mechanical neck pain (MNP) is a commonly occurring musculoskeletal condition that is usually managed using electrical modalities, joint mobilization techniques, and therapeutic exercises, but has limited evidence of their efficacy. Pathology (densification) of the deep cervical fascia that occurs due to the increased viscosity of hyaluronic acid (HA) may induce neck pain and associated painful symptoms of the upper quarter region. Fascial manipulation (FM) and yoga poses are considered to reduce the thixotropy of the ground substances of the deep fascia and improve muscle function. The purpose of this study is to investigate the effect of FM and sequential yoga poses (SYP) when compared to the usual care on pain, function, and oculomotor control in MNP. Methods: This FaCe-Man trial will recruit 160 patients with subacute and chronic mechanical neck pain diagnosed using predefined criteria. Participants will be randomized to either the intervention group or the usual care group, using a random allocation ratio of 1:1. Patients in the intervention group will receive FM (4 sessions in 4 weeks) and SYP (12 weeks) whereas the standard care group will receive cervical mobilization/ thoracic manipulation (4 sessions in 4 weeks) and therapeutic exercises (12 weeks). The primary outcome is the change in the numeric pain rating scale (NPRS). The secondary outcomes include changes in the patient-specific functional scale and oculomotor control, myofascial stiffness, fear-avoidance behavior questionnaire, and elbow extension range of motion during neurodynamics test 1. Discussion: If found effective, FM along with SYP investigated in this trial can be considered as a treatment strategy in the management of mechanical neck pain. Considering the magnitude of the problem, and the pragmatic and patient-centered approach to be followed, it is worth investigating this trial. Trial registration: ClinicalTrials.gov CTRI/2020/01/022934. Registered on January 24, 2020 with ctri.nic.in. Clinical Trials Registry – India.
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U2 - 10.1186/s13063-021-05533-w
DO - 10.1186/s13063-021-05533-w
M3 - Article
AN - SCOPUS:85113737670
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 574
ER -