NCT04856813

Brief Summary

It is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

April 6, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2022

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

April 6, 2021

Last Update Submit

November 1, 2022

Conditions

Neck PainChronic Pain

Keywords

neck painexerciseEnduranceTrainingIntervention

Outcome Measures

Primary Outcomes (1)

  • Change in Neck disability

    Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).

    Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.

Secondary Outcomes (6)

  • Change in pain perception

    Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.

  • Change in Range of motion (ROM)

    Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.

  • Change in craniocervical flexion

    Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.

  • Change in kinesophobia

    Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.

  • Change in Catastrophism

    Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.

  • +1 more secondary outcomes

Study Arms (2)

active

EXPERIMENTAL

this is the group that does a treatment with active movement, a program of pain education and a program of home exercise.

Other: Manual therapy active

non active

ACTIVE COMPARATOR

this is the group that does a treatment without active movement, a program of pain education and a program of home exercise.

Other: Manual therapy

Interventions

Manual therapy activeOTHER

massage or ischemic compression with active contraction, tha will be isometric or concentric.

active
Manual therapyOTHER

massage or isquemic compression without contraction

non active

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • accept to participate in the study, through informed consent
  • subjects with chronic nonspecific neck pain lasting equal to or more than 3 months

You may not qualify if:

  • Present neck pain caused by serious pathology such as: inflammatory, congenital, infectious, metabolic and neoplastic diseases.
  • Cervical pathology of traumatic origin with less than 6 months of evolution.
  • Rheumatic diseases.
  • Neck pain with neurological signs such as: radiculopathy and myelopathy.
  • Previous surgery of the cervical spine.
  • Pregnancy.
  • Have the intention of receiving other physiotherapeutic treatments different from the one proposed during the study period.
  • Present serious mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexander achalandabaso

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Neck PainChronic PainMotor Activity

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Alexander Achalandabaso

    University of Jaen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: blind
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapy doctor

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 23, 2021

Study Start

August 1, 2021

Primary Completion

December 9, 2021

Study Completion

July 9, 2022

Last Updated

November 2, 2022

Record last verified: 2022-11

Locations

ES(1)