Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain
Primary Purpose
Chronic Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Neck Pain
Eligibility Criteria
Inclusion Criteria:
- Nonspecific cervical pain of more than 12 weeks of evolution.
- Over 18 years.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Alcala
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Manual Therapy Group
Therapeutic Exercise Group
Arm Description
Manipulation of the high dorsal region in extension. Cervical mobilizations. Massage therapy. Suboccipital inhibition. Once a week.
Recruitment and strengthening of the cervical flexors. Isometric cervical exercises with self-resistance. Shoulder girdle strengthening exercise. Alternating days.
Outcomes
Primary Outcome Measures
Neck Disability Index
Secondary Outcome Measures
Visual Analog Scale
Pressure Pain Threshold
Life Quality SF-12
Kinesiophobia TAMPA Scale
Beck Depression Inventory II
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05255055
Brief Title
Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain
Official Title
Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain - Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Therapy Group
Arm Type
Experimental
Arm Description
Manipulation of the high dorsal region in extension. Cervical mobilizations. Massage therapy. Suboccipital inhibition. Once a week.
Arm Title
Therapeutic Exercise Group
Arm Type
Experimental
Arm Description
Recruitment and strengthening of the cervical flexors. Isometric cervical exercises with self-resistance. Shoulder girdle strengthening exercise. Alternating days.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
A manual therapy protocol and a therapeutic exercise protocol
Primary Outcome Measure Information:
Title
Neck Disability Index
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Time Frame
Three months
Title
Pressure Pain Threshold
Time Frame
Three months
Title
Life Quality SF-12
Time Frame
Three months
Title
Kinesiophobia TAMPA Scale
Time Frame
Three months
Title
Beck Depression Inventory II
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nonspecific cervical pain of more than 12 weeks of evolution.
Over 18 years.
Exclusion Criteria:
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.
Facility Information:
Facility Name
University of Alcala
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain
We'll reach out to this number within 24 hrs