NCT05246826

Brief Summary

The aim of this study is to investigate the effects of clinical pilates exercises and electrotherapy on pain level, physical condition, functional status and psychosocial status in patients with chronic neck pain.In the study, individuals will be divided into two groups. Pilates will be applied to one group for 6 weeks, pilates and conventional therapy will be applied to one group. Individuals will be evaluated before and after treatment. In the evaluation, pain, disability, anxiety and depression status, quality of life of individuals will be questioned. In addition, cervical joint range of motion and endurance will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

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

First Submitted

Initial submission to the registry

February 9, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

February 9, 2022

Last Update Submit

October 13, 2022

Conditions

Keywords

pilatesconvantional therapychronic neck pain

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale (VAS)

    Pain intensity will be evaluated by VAS. Individuals are asked to mark the intensity of pain. felt on a 10-centimeter horizontal line. The score obtained by measuring with a tape measure will be used in the analysis. High scores are associated with increased pain. 0 means no pain, 10 means untolerable pain.

    6 weeks

Secondary Outcomes (12)

  • Cervical Normal Joint Movement

    6 weeks

  • Cervical Flexor Muscle Endurance Test

    6 weeks

  • Cervikal Extensor Muscle Endurance Test

    6 weeks

  • Strength and Endurance of Deep Cervical Flexors

    6 weeks

  • Functional Status-Neck Disability Index

    6 weeks

  • +7 more secondary outcomes

Study Arms (2)

Clinical Pilates Exercises

EXPERIMENTAL

Pilates exercises will be performed 3 days a week, for a total of 18 sessions for 6 weeks.

Other: Clinical Pilates Exercises

Clinical Pilates Exercises and Conventional Treatment

EXPERIMENTAL

In addition to Pilates exercises, conventional treatment will be performed 3 days a week, for 6 weeks, a total of 18 sessions.

Other: Clinical Pilates Exercises and Conventional Treatment

Interventions

Pilates exercises; warm-up and cool-down exercises will be performed for 5 repetitions, while other exercises will be performed by the same physiotherapist as 10 repetitions depending on the patient's pain and fatigue. The exercises will be advanced at the end of the 3rd week.

Clinical Pilates Exercises

In addition to pilates exercises, a conventional treatment program will be applied. As part of the conventional treatment program, 20 minutes of Hotpack to the cervical area, 20 minutes of conventional Transcutaneous Electrical Nerve Stimulation (TENS) to the painful area (80 Hertz (Hz), 100 microseconds (μs), until tingling is felt, asymmetrical biphasic rectangular waveform), 8 minutes to the cervical area Ultrasound (US) (4 minutes + 4 minutes, 1.5 watts/cm2, 1 MHz, continuous) will be applied.

Clinical Pilates Exercises and Conventional Treatment

Eligibility Criteria

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

You may qualify if:

  • years old
  • Individuals with neck pain lasting longer than 3 months
  • Individuals with a score of 3 or more according to VAS

You may not qualify if:

  • Those with a history of surgery
  • Those who have received physical therapy for the neck region in the last 6 months
  • With pregnancy status
  • Cancer, infectious disease
  • With inflammatory disease
  • With neurological disease
  • Joint injection in the last 3 months
  • Individuals using analgesics, myorelaxants, or antidepressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gizem Vaiz Haklıgil

Famagusta, 99628, Cyprus

Location

Study Officials

  • SEVİM ÖKSÜZ, Asst. Prof.

    Eastern Mediterranean University

    STUDY DIRECTOR
  • Ender Angın, Assoc. Prof.

    Eastern Mediterranean University

    STUDY DIRECTOR

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 ınvestigator

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 18, 2022

Study Start

February 9, 2022

Primary Completion

August 20, 2022

Study Completion

August 30, 2022

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations