The Effectiveness of Manipulation Treatment in Cervical Region

NCT04455048 | Completed

• 1 other identifier: AIBU-FTR-RK-04
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population (1, 2). Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor (3, 4).

Conditions

Neck Pain

Keywords

Tape; Pain; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Pain pressure threshold

  Pain pressure threshold (PPT). was assessed with an analogue algometry (Baseline, FEl Inc. White Plains, NY,USA) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.

  two weeks

Secondary Outcomes (4)

• Visual analog scale

  two weeks

• Cervical range of motion

  two weeks

• Neck Disability Index

  two weeks

• Global Perceived Effect Scale

  two weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

A single-session manipulation with a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied each week for two weeks.

Other: Cervicothoracic thrust manipulation

Control Group

SHAM COMPARATOR

A sham manipulation without a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied.

Other: Cervicothoracic thrust manipulation sham

Interventions

Cervicothoracic thrust manipulation OTHER

The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. Thrust manipulation will be applied at the end of exhale.

Intervention Group

Cervicothoracic thrust manipulation sham OTHER

The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. A soft compression will be applied at the end of exhale without a thrust.

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis Nonspecific neck pain (NSNP)
• Symptoms should last longer than 2 weeks

You may not qualify if:

• Any known cause such as radiculopathy or neurological diseases,
• History of neck surgery,
• History of vertebral fracture,
• Osteoporosis,
• Tumor or a mass in the vertebral column,
• Any spinal thrust manipulation contraindication,
• Medication usage such as antiinflammatory or analgesic which might effect outcome assessments,
• History of spinal manipulation

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (2)

Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

Health Sciences Faculty Bolu Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Erdal Dilekçi, MD

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

• Ramazan KURUL, Ph.D

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The manipulation group will receive a single session thrust manipulation and the control group will receive a sham manipulation. Outcome assessment will be performed by another investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two groups with a sham control. Assessments will be performed before manipulation, immediately after first session, in the second week, and two months after the last session.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: February 2, 2019
• Primary Completion: March 16, 2023
• Study Completion: April 15, 2023
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after study published and will be available indefinetly.
• Access Criteria: data will be accessed from cloud store link

Locations

TU (2)