NCT04350918

Brief Summary

Neck pain is becoming increasingly common throughout the world with a considerable impact on individuals, communities, health-care systems and businesses (Hoy et al, 2011).Neck pain is a common problem within our society affecting individual's physical and social functioning considerably and interfering with the patient's daily activities. There is lack of evidence to allow conclusions to be drawn about the effectiveness of MET when compared with stretching exercises for relieving mechanical neck pain. Therefore, this study is designed to examine the effect of MET, static stretching and to compare their effects on pain intensity and functional disability in patient with mechanical neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

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

May 23, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

April 15, 2020

Last Update Submit

April 16, 2020

Conditions

Keywords

Static stretching, ,neck pain,muscle energy techniquesvisual analogue scale,neck disability index

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    VAS is a one-dimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases (Mc Cormack et al, 1988). pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) (Aun et al, 1986)

    From March 2019 to November 2019, The treatment for each patient was for 6 weeks

Secondary Outcomes (1)

  • Neck Disability Index (NDI)

    From March 2019 to November 2019, The treatment for each patient was for 6 weeks

Study Arms (2)

Muscle Energy Technique (MET)

EXPERIMENTAL

MET Group received 12 treatment sessions of MET (Nagrale et al, 2010) two times a week in addition to conventional physiotherapy. The procedures employ voluntary muscle contractions by the patient in a precisely controlled direction and intensity against a counterforce applied by the Physiotherapist. The technique requires the therapist to provide stabilization to the segment on which the distal aspect of the muscle attaches. A command for anisometric contraction of the muscle is given that causes accessory movement of the joint. Several specific muscle energy techniques are described for the subcranial region of the cervical spine.

Device: Muscle Enery Techniques

Static stretching (SS)

EXPERIMENTAL

Subjects in SS Group received 12 treatment sessions of static stretching (Dutton et al, 2008) two times a week in addition to conventional physiotherapy. Stretching involves the application of manual or mechanical force to elongate structures that have adaptively shortened and are hypo-mobile (Sullivan, 2007) Static stretching involves stretching a muscle to a point of discomfort and holding the stretch for a length of time, followed by a return to normal resting muscle length (Andrews et al, 2004). Muscles of the neck were stretched in especially in side flexion, extension, flexion and side rotation for 10 seconds and was repeated 10 times for a session.

Device: Static Stretching

Interventions

Group of patients that underwent muscle energy technique as a mean of treatment for the complaint

Also known as: MET
Muscle Energy Technique (MET)

Set of patients that had static stretching technique for the treatment for the complaint

Also known as: SS
Static stretching (SS)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients with acute neck pain
  • Subjects were excluded if they have neck pain associated with an underlying pathology such as fracture of the cervical spine, neck pain radiating into the arms or upper extremity or associated with headaches or facial pain, malignancy, infections, inflammatory disorders, osteoporosis or cases of disc prolapse.
  • Patients with history of surgery of the cervical spine during the previous 12months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obafemi Awolowo University

Ile-Ife, Osun State, 220005, Nigeria

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Adesola O Ojoawo PhD

    Head, Department of Medical Rehabilitation, Obafemi Awolowo University Ile Ife

    PRINCIPAL INVESTIGATOR
  • Kayode Ijaduola

    Provost, College of Health Sciences, Obafemi Awolowo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects for this study were patients diagnosed of mechanical neck pain in Physiotherapy Outpatient Department of Obafemi Awolowo University Teaching Hospital Complex (OAUTHC), Ile-Ife. Individuals who meet the inclusion criteria were randomly allocated to Muscle Energy Techniques Group and Static Stretching Group using the simple random assignment method without replacement (Fish Bowl).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr and Head of Department

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

May 23, 2019

Primary Completion

December 24, 2019

Study Completion

January 16, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations