NCT05255055

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

January 20, 2022

Last Update Submit

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

EXPERIMENTAL

Manipulation of the high dorsal region in extension. Cervical mobilizations. Massage therapy. Suboccipital inhibition. Once a week.

Other: Physical Therapy

Therapeutic Exercise Group

EXPERIMENTAL

Recruitment and strengthening of the cervical flexors. Isometric cervical exercises with self-resistance. Shoulder girdle strengthening exercise. Alternating days.

Other: Physical Therapy

Interventions

A manual therapy protocol and a therapeutic exercise protocol

Manual Therapy GroupTherapeutic Exercise Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

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

Locations