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

NCT05568394 | Completed DMC

• 1 other identifier: FF-65 2301484
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline and post-intervention

Secondary Outcomes (7)

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

  At baseline and post-intervention

• Neck pain intensity

  At baseline and post-intervention

• Neck pain and disability

  At baseline and post-intervention

• Anxiety and depression

  At baseline and post-intervention

• Cervical range of motion

  At baseline and post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Manual therapy and therapeutic exercise

Other: Manual therapy combinded with therapeutic exercise

Control group

EXPERIMENTAL

Routine physical therapy

Other: Routine physical therapy

Interventions

Manual therapy combinded with therapeutic exercise OTHER

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 group

Routine physical therapy OTHER

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).

Control group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of Physical Therapy, Faculty of Associated Medical Sciences

Chiang Mai, 50202, Thailand

Location

Related Publications (8)

• Jull G, Falla D, Treleaven J, O'Leary S. Management of neck pain disorders: a research informed approach. Edinburgh: Elseiver Limited; 2019.

  BACKGROUND

• Johnston V, O'Leary S, Comans T, Straker L, Melloh M, Khan A, Sjogaard G. A workplace exercise versus health promotion intervention to prevent and reduce the economic and personal burden of non-specific neck pain in office personnel: protocol of a cluster-randomised controlled trial. J Physiother. 2014 Dec;60(4):233; discussion 233. doi: 10.1016/j.jphys.2014.08.007. Epub 2014 Oct 11.

  PMID: 25306220 BACKGROUND

• Sremakaew M, Jull G, Treleaven J, Barbero M, Falla D, Uthaikhup S. Effects of local treatment with and without sensorimotor and balance exercise in individuals with neck pain: protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2018 Feb 13;19(1):48. doi: 10.1186/s12891-018-1964-3.

  PMID: 29433500 BACKGROUND

• Maitland GD, Hengeveld E, Banks K, Anglaise K. Vertebral manipulation. 7th ed. Oxford: Butterworth-Heinemann: Elsevier; 2005.

  BACKGROUND

• de Zoete RMJ, Stanwell P, Weber KA, Snodgrass SJ. Differences in Structural Brain Characteristics Between Individuals with Chronic Nonspecific Neck Pain and Asymptomatic Controls: A Case-Control Study. J Pain Res. 2022 Feb 18;15:521-531. doi: 10.2147/JPR.S345365. eCollection 2022.

  PMID: 35210851 BACKGROUND

• Coppieters I, De Pauw R, Caeyenberghs K, Lenoir D, DeBlaere K, Genbrugge E, Meeus M, Cagnie B. Differences in white matter structure and cortical thickness between patients with traumatic and idiopathic chronic neck pain: Associations with cognition and pain modulation? Hum Brain Mapp. 2018 Apr;39(4):1721-1742. doi: 10.1002/hbm.23947. Epub 2018 Jan 11.

  PMID: 29327392 BACKGROUND

• Didehdar D, Kamali F, Yoosefinejad AK, Lotfi M. The effect of spinal manipulation on brain neurometabolites in chronic nonspecific low back pain patients: a randomized clinical trial. Ir J Med Sci. 2020 May;189(2):543-550. doi: 10.1007/s11845-019-02140-2. Epub 2019 Nov 26.

  PMID: 31773541 BACKGROUND

• Chaikla R, Sremakaew M, Kothan S, Saekho S, Wantanajittikul K, Uthaikhup S. Effects of manual therapy combined with therapeutic exercise versus routine physical therapy on brain biomarkers in patients with chronic non-specific neck pain in Thailand: a study protocol for a single-blinded randomised controlled trial. BMJ Open. 2023 Apr 24;13(4):e072624. doi: 10.1136/bmjopen-2023-072624.

  PMID: 37094892 DERIVED

MeSH Terms

Conditions

Neck Pain; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Sureeporn Uthaikhup, PhD.

  Department of physical therapy, Chiang Mai university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-blinded design

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 5, 2022
• Study Start: November 15, 2022
• Primary Completion: November 28, 2023
• Study Completion: February 5, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)