Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain

Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain - Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • University of Alcala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Therapy Group; Manipulation of the high dorsal region in extension. Cervical mobilizations. Massage therapy. Suboccipital inhibition. Once a week.	Other: Physical Therapy; A manual therapy protocol and a therapeutic exercise protocol
Experimental: Therapeutic Exercise Group; Recruitment and strengthening of the cervical flexors. Isometric cervical exercises with self-resistance. Shoulder girdle strengthening exercise. Alternating days.	Other: Physical Therapy; A manual therapy protocol and a therapeutic exercise protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neck Disability Index	Three months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 24, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: UAH/2022/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No