Pain Education Added to Conventional Physiotherapy Program for Patients With Neck Pain

NCT05210257 | Completed

• 1 other identifier: ozdenyasarer neck pain
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The aim of this study is to examine the effects of pain training applied with conventional physiotherapy on pain, range of motion, disability, kinesiophobia and quality of life in patients with neck pain. Methods: The research is planned to be completed within 18 months at Istanbul Hospital. It is planned to include 40 individualsbetween the ages of 18-65 with neck pain persisting for 3 months or more.Individuals will be randomly divided into 2 groups. Conventional physiotherapy program will be applied to the first group. Conventional physiotherapy will be applied to the second group and neuroscience education will be given.Pain intensity will evaluate before and after exercise with 'Visual Analog Scale' (VAS), and algometer,range of motion will evaluate with C-ROM, kinesiofobia will questioned with Tampa Kinesiofobia Score, Quality of life will evaluate with Nottingham Health Profile, whereas the level of neck disability will evaluate before and after exercise with 'Neck Pain and Disability Score' (NPDS). The obtained results will analyze using appropriate statistical methods.

Conditions

Neck Pain; Pain

Outcome Measures

Primary Outcomes (7)

• Pain Intensity

  Self reported pain intensity .. Pain intensity was evaluated before and after exercise with 'Visual Analog Scale'. Each item scored is 0-10 (0=no pain 10=pain as bad as can be)

  8 weeks

• Range Of Motion

  The CROM (Cervical Range-of-Motion Instrument) combines AMA-required inclinometers and magnets in an easy-to-use instrument. It eliminates positioning, zeroing and tracking errors that are common with stand-alone inclinometers. Standardized protocol minimizes the chance of examination error.

  8 weeks

• Kinesiofobia

  Self reported. The Nottingham Health Profile (NHP) was originally created as a standardised tool to survey health problems and measure medical or social interventions. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life.

  8 weeks

• Disability

  Self reported. The level of neck disability was evaluated before and after exercise with 'Neck Pain and Disability Score' . Each question is measured on a scale from 0 (no disability) to 5, and an overall score out of 100 is calculated by adding each item score together.

  8 weeks

• Quality of life level

  Self reported. The Nottingham Health Profile (NHP) was originally created as a standardised tool to survey health problems and measure medical or social interventions. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life.

  8 weeks

• Pain pressure threshold

  Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.

  8 weeks

• Pain knowledge

  Self reported. The Neurophysiology of Pain Questionnaire (NPQ) was devised to assess how an individual conceptualizes the biological mechanisms that underpin his or her pain. presents 12 items, and the answer options also consist of "true, false or undecided". Its psychometric properties constitute a one- -dimensional scale with good test-retest reliability. The results are interpreted as follows: each hit corresponds to one point, if the individual makes a mistake or choose the "undecided" alternati- ve, the item is reset to zero; therefore, the score ranges from zero to 12, and the higher the score, the greater the level of unders- tanding of the mechanisms present in pain

  8 weeks

Study Arms (2)

Conventional physiotherapy

OTHER

Conventional physiotherapy program consists of neck isometric exercises, neck isotonic exercises, stabilization exercises, stretching exercises and posture exercises and physiotherapy agents.

Other: Conventional physiotherapy

Neuroscience education

ACTIVE COMPARATOR

Conventional physiotherapy program and The neuroscience education trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions.

Other: Neuroscience education

Interventions

Conventional physiotherapy OTHER

Group 1 was given conventinal physiotherapy Physiotherapy agents; 5 min ultrasound 1.5 watts/cm2 20 min conventional TENS 20 min heat agent application (hot pack) Exercise program; Stretching and relaxation exercises, Neck strengthening exercises that include concentric and isometric contractions Posture exercises 3 sets per day, 1 in the hospital with 10 repetitions

Conventional physiotherapy

Neuroscience education OTHER

Conventional physiotherapy program and The neuroscience education trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions. In sessions ; neurons and nerve conduction in the session, the formation process of pain, peripheral neuropathic pain, pain spread during the session, neuroplasticity, peripheral and central sensitization, hyperalgesia and allodynia, acute-chronic pain, The effects of stress, fear, anxiety, false thoughts and beliefs about pain and other psychosocial factors on the pain process and determining possible psychosocial factors in the patient during the session, Strategies for controlling the pain process and coping with psychosocial factors in the session will be completed by explaining the effect mechanisms of exercise on pain.

Neuroscience education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages of 18-65
• neck pain that persists for 3 months or more

You may not qualify if:

• Patients undergoing cervical surgery
• Patients with neck pain secondary to neurological or vascular disease or neoplasia
• Patients with radiculopathy with neurological deficits
• Patients with a history of inflammatory or infective arthritis of the cervical spine
• Patients who received a physical therapy program in the last 6 months
• Patients with pain in the scapula, shoulder, upper extremity or lumbar region that may interfere with neck stabilization exercises

Sponsors & Collaborators

• Istanbul Arel University: lead

Study Sites (1)

Özden YAŞARER

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 27, 2022
• Study Start: September 15, 2022
• Primary Completion: June 6, 2023
• Study Completion: July 1, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

TU (1)