Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain
1 other identifier
interventional
40
1 country
1
Brief Summary
It has been estimated that between 50% and 85% of the population will suffer neck pain along their life. Chronic nonspecific neck pain is one of the main causes of disability in the population, it represents 25% of visits to physiotherapy, and it also has a high chance of chronification. The efficacy of combining manual therapy and therapeutic exercise for the treatment of this pathology has been demonstrated a lot of times. However, no conclusive studies have been found that compare the isolated application of both treatments, thus being an important focus of action and research. The main objective of the study is to check if the treatment with therapeutic exercise is better than manual therapy in the improvement of the disability in patients with chronic neck pain. A randomized, controlled, monocentric, parallel and single-blind clinical trial will be carried out. The simple will be obtained from the population over 18 years old with chronic neck pain of more than 12 weeks of evolution and will be those who meet the inclusion and exclusion criteria. The patients will be randomly divided into 2 intervention groups, in one of the groups will be applied a manual therapy session of about 30 minutes once a week for 4 weeks. In the other group it will be delivered and explained to the patients, a home therapeutic exercise program that will be carried out on alternate days for 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
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
Study Start
First participant enrolled
January 12, 2022
CompletedFirst Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2022
CompletedDecember 28, 2022
December 1, 2022
8 months
January 20, 2022
December 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Neck Disability Index
Three months
Secondary Outcomes (5)
Visual Analog Scale
Three months
Pressure Pain Threshold
Three months
Life Quality SF-12
Three months
Kinesiophobia TAMPA Scale
Three months
Beck Depression Inventory II
Three months
Study Arms (2)
Manual Therapy Group
EXPERIMENTALManipulation of the high dorsal region in extension. Cervical mobilizations. Massage therapy. Suboccipital inhibition. Once a week.
Therapeutic Exercise Group
EXPERIMENTALRecruitment and strengthening of the cervical flexors. Isometric cervical exercises with self-resistance. Shoulder girdle strengthening exercise. Alternating days.
Interventions
A manual therapy protocol and a therapeutic exercise protocol
Eligibility Criteria
You may qualify if:
- Nonspecific cervical pain of more than 12 weeks of evolution.
- Over 18 years.
You may not qualify if:
- Oncological processes.
- Pregnancy.
- Infectious diseases.
- Degenerative diseases.
- Fibromyalgia.
- Previous spinal surgeries.
- Previous traumatic events.
- Hernias and/or cervical protrusions.
- Neurological processes.
- Current treatment for cervical pain.
- Neuropathic characteristics pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alcala
Alcalá de Henares, Madrid, 28805, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
January 20, 2022
First Posted
February 24, 2022
Study Start
January 12, 2022
Primary Completion
September 22, 2022
Study Completion
December 23, 2022
Last Updated
December 28, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share