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

Primary Purpose

Neck Pain

Status

Recruiting

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Manual therapy combinded with therapeutic exercise

Routine physical therapy

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, Manual therapy, Exercise, Magnetic resonance imaging, Magnetic resonance spectroscopy

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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)

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.

Sites / Locations

Department of Physical Therapy, Faculty of Associated Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intervention group

Control group

Arm Description

Manual therapy and therapeutic exercise

Routine physical therapy

Outcomes

Primary Outcome Measures

Cortical gray matter: volume and thickness

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

Neurochemical biomarkers: N-acetylaspartate (NAA), creatine (Cr), glutamic acid/glutamine (Glu/Gln), myoinositol (mI), and choline (cho)

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

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

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

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

Cervical range of motion (degrees) will be measured in flexion, extension, left-right lateral flexion and left-right rotation.

Cervical muscle strength

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)

White matter in the brain will be quantified using diffusion tensor imaging (DTI) technique.

Full Information

NCT ID

NCT05568394

First Posted

October 4, 2022

Last Updated

August 29, 2023

Sponsor

Chiang Mai University

1. Study Identification

Unique Protocol Identification Number

NCT05568394

Brief Title

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

Official Title

Effects of Manual Therapy Combined With Therapeutic Exercise on Brain Biomarkers in Patients With Chronic Nonspecific Neck Pain: Study Protocol for a Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2022 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chiang Mai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

Keywords

Neck pain, Manual therapy, Exercise, Magnetic resonance imaging, Magnetic resonance spectroscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A single-blinded design

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Manual therapy and therapeutic exercise

Arm Title

Control group

Arm Type

Experimental

Arm Description

Routine physical therapy

Intervention Type

Other

Intervention Name(s)

Manual therapy combinded with therapeutic exercise

Intervention Description

The treatment includes cervical mobilization and specific therapeutic exercises: craniocervical and cervical flexors and extensors, axioscapular muscles, and postural correction (30-40 minutes). The participants will attend 20 individual treatment sessions (2 visits per week for 10 weeks).

Intervention Type

Other

Intervention Name(s)

Routine physical therapy

Intervention Description

The treatment includes routine physical therapy (e.g., modalities, range of motion and/or gentle stretching exercise) (30-40 minutes). The participants will attend 20 individual treatment sessions (2 visits per week for 10 weeks).

Primary Outcome Measure Information:

Title

Cortical gray matter: volume and thickness

Description

Time Frame