Effects of Manual Therapy Combined With Therapeutic Exercise on Brain Biomarkers in Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Other: Manual therapy combinded with therapeutic exercise; Other: Routine physical therapy

• Registration Number: NCT05568394
• Lead Sponsor: Chiang Mai University

Brief Summary

Structural brain alterations in pain-related areas have been demonstrated in patients with nonspecific neck pain. While manual therapy combined with therapeutic exercise is an effective management for neck pain, its underlying mechanisms are poorly understood. The primary objective of this trial is to investigate the effects of manual therapy combined with therapeutic exercise on brain imaging biomarkers in patients with chronic nonspecific neck pain. The secondary objectives are to assess neurochemical biomarkers, clinical features of neck pain, cervical range of motion and cervical muscle strength.

Detailed Description

This study is a single-blinded, randomized controlled trial. Forty-eight participants with chronic nonspecific neck pain will be recruited into the study. Participants will be randomly allocated to either an intervention or control group (1:1 ratio). Participants in the intervention group will receive manual therapy combined with therapeutic exercise for 10 weeks (2 visits per week). The control group will receive routine physical therapy. Primary outcomes are brain imaging biomarkers (cortical gray matter: volume, thickness and area, and white matter: fractional anisotropy and mean diffusivity) in pain-related areas. Secondary outcomes are neurochemical biomarkers (N-acetylaspartate, NAA; creatine, Cr; glutamic acid/glutamine, Glu/Gln; myoinositol, mI; and choline, cho), clinical features (neck pain intensity, duration, neck disability and psychological symptoms), cervical range of motion and cervical muscle strength.

Study Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-05
• Study Start: 2022-11-15
• Primary Completion: 2023-11-28
• Status Verified: 2024-02
• Study Completion: 2024-02-05
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• a history of nonspecific neck pain for ≥ 3 months
• an average pain intensity over the past week ≥ 35 mm. on a visual analogue scale (VAS)

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Exclusion Criteria

• a history of head and neck injury or surgery
• known or suspected vestibular pathology or dizziness caused by underlying pathology in the ear, brain and sensory nerve pathways (e.g. benign paroxysmal positional vertigo) and/or vascular disorders
• any neurological or musculoskeletal condition that could affect the outcomes (e.g., scoliosis, torticollis, myofascial pain syndrome, fibromyalgia and rheumatoid arthritis)
• metabolic conditions (e.g., diabetes, obesity (BMI > 30 kg/m2) and hypertension)
• psychological symptoms (e.g., anxiety, depression and schizophrenia)
• contraindications to MRI (e.g., pregnancy/breastfeeding, claustrophobia and ferromagnetic implants)
• receiving physiotherapy treatment for their neck conditions in the past 12 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Manual therapy combinded with therapeutic exercise	Manual therapy and therapeutic exercise
Control group	Routine physical therapy	Routine physical therapy

Primary Outcome Measures

Name	Time	Method
Cortical gray matter: volume and thickness	At baseline and post-intervention	Cortical gray matter (volume and thickness) will be measured in pain-related areas (thalamus, prefrontal cortex (PFC), primary somatosensory cortex (S1), primary motor cortex (M1), insula, cingulate cortex, precuneus, temporal lobe and periaqueductal gray matter) using a Magnetic resonance imaging (MRI) machine

Secondary Outcome Measures

Name	Time	Method
Neurochemical biomarkers: N-acetylaspartate (NAA), creatine (Cr), glutamic acid/glutamine (Glu/Gln), myoinositol (mI), and choline (cho)	At baseline and post-intervention	Neurochemistry biomarkers will be measured using single-voxel proton magnetic resonance spectroscopy (1H-MRS) in dorsolateral prefrontal cortex (DLPFC), primary somatosensory cortex (S1), anterior cingulate (ACC), insula and thalamus.
Neck pain intensity	At baseline and post-intervention	The average intensity of neck pain will be assessed by using a 0-10 cm visual analogue scale (VAS), with 0 indicating no pain and 10 indicating worst imaginable pain.
Neck pain and disability	At baseline and post-intervention	Neck Disability Index (NDI) will be used to assess how neck pain affects a patient's daily life and to assess the self-rated disability. A total score is 50, which a higher score indicates a higher disability.
Anxiety and depression	At baseline and post-intervention	The symptoms of anxiety and depression will be assessed using Hospital Anxiety and Depression Scale (HADS). It includes two subscales: anxiety (HADS-A) and depression (HADS-D). A total score for each subscale ranges from 0 to 21, with higher scores indicating worse symptoms.
Cervical range of motion	At baseline and post-intervention	Cervical range of motion (degrees) will be measured in flexion, extension, left-right lateral flexion and left-right rotation.
Cervical muscle strength	At baseline and post-intervention	Cervical muscle strength will be measured in a craniocervical flexion action, using a handheld dynamometer (Newtons).
White matter integrity: fractional anisotropy (FA) and mean diffusivity (MD)	At baseline and post-intervention	White matter in the brain will be quantified using diffusion tensor imaging (DTI) technique.

Trial Locations

Locations (1)

Department of Physical Therapy, Faculty of Associated Medical Sciences; 🇹🇭 Chiang Mai, Thailand