NCT05797025

Brief Summary

This study aims to determine whether there is a difference in pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

March 16, 2023

Last Update Submit

September 13, 2023

Conditions

Keywords

Pressure Pain ThresholdNeckNeck PainPinch Grip StrengthQuality of life

Outcome Measures

Primary Outcomes (5)

  • Pressure pain threshold

    Pressure pain threshold will be measured using Baseline® dolorimeter (Fabrication Enterprises, White Plains, NY, USA). Pressure pain thresholds of the upper trapezius, sternocleidomastoid, levator scapula, and suboccipital region muscles (semispinalis capitis and splenius capitis) will be evaluated. Two measurements will be taken from all muscles in the same order and with five minutes intervals. The average of the measurements will be recorded in kilograms/centimeter2 (kg/cm2). The procedure will be explained to individuals by showing them by manual palpation before testing begins. Pressure pain threshold measurement with algometer has been reported as a valid and reliable method.

    1 day

  • Pinch grip strength

    Baseline® pinch meter (Mechanical Pinch Gauges, NexGen Ergonomics, Inc. Montreal, Canada) will be used to assess pinch grip strength. While measuring pinch grip strength, patients will be asked to place the pinch meter between the pulp of the thumb and index finger and squeeze with all their strength. All measurements will be performed in 3 repetitions with one-minute intervals on the right and left hands. The average of the obtained values will be recorded in kilogram force.

    1 day

  • Neck disorders

    Neck disorders will be assessed with the Bournemouth Questionnaire (BQ). BQ consists of 7 questions that examine pain intensity, activities of daily living, social activities, anxiety, emotional aspects of depression, kinesiophobia, and ability to control pain. The items in the questionnaire are specific to patients with neck pain, and each question evaluates a different parameter. A high score indicates a high degree of discomfort. The Turkish version of the BQ has been proven to be valid and reliable.

    1 day

  • Arm, shoulder, and hand problems

    Arm, shoulder, and hand problems will be evaluated with the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The questionnaire consists of a disability/symptom scale (11 items) and two optional scales: work (four items) and sports/performing arts (four items). In the disability/symptom scale, each item questions the severity of pain, activity-related pain, tingling, weakness and stiffness, difficulty in performing physical activity due to upper extremity problems, and the effect of upper extremity problems on social activities, work, and sleep. Answers are given on a scale of one to five, and each question is scored from 1 to 5. Scores on the three subscales of the DASH disability/symptom scale, the work scale, and the sports/performing arts scale all range from 0 (no disability) to 100 (most severe disability). The Turkish version of DASH has been reported to be valid and reliable.

    1 day

  • General quality of life assessed by NHP

    The Nottingham Health Profile (NHP) is a general quality of life questionnaire that measures a person's perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items. Questions are answered as 'yes' or 'no'. The questionnaire assesses six parameters related to health status. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), and emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, and 100 indicates worst health. The total NHP score is derived from the sum of the subscores.

    1 day

Study Arms (2)

Individuals with neck pain

OTHER

To assess pressure pain threshold and pinch grip strengths.

Other: To assess pressure pain threshold and pinch grip strengths.

Healthy group

OTHER

To assess pressure pain threshold and pinch grip strengths.

Other: To assess pressure pain threshold and pinch grip strengths.

Interventions

To assess pressure pain threshold and pinch grip strengths.

Healthy groupIndividuals with neck pain

Eligibility Criteria

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

You may qualify if:

  • Complaining of neck pain for more than three months,
  • With any chronic disease diagnosed,
  • No past or present mental illness,
  • Individuals who can speak, read and write Turkish.

You may not qualify if:

  • Having any neurological, psychiatric or cognitive disorder,
  • Individuals who cannot speak, read or write Turkish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 16, 2023

First Posted

April 4, 2023

Study Start

April 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations