NCT03965884

Brief Summary

The aim of the study is to investigate the efficacy of connective tissue massage and lumbar stabilization exercise treatment on pain severity, functional capacity and quality of life in those who have experienced peripheral neuropathy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

May 12, 2019

Last Update Submit

October 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    visual analogue scale measures pain on a horizontal 100mm line. The most left side on this line is defined no pain and the most right side is defined as 'the most severe pain imaginable'. Patients mark a point on the line according to the pain they feel. The pain level is measured in millimeters from the left to the marked point. we evaluate the current pain, the usual pain in the last month, the worst pain in the last month.

    six week

Secondary Outcomes (3)

  • Short Pain Inventory

    six week

  • Neuropathic Pain Impact on Quality of Life questionnaire

    six week

  • Neuropathic Pain Scale

    six week

Study Arms (3)

lumbal stabilization exercise group

EXPERIMENTAL
Other: Physical therapy and rehabilitation

connective tissue massage group

EXPERIMENTAL
Other: Physical therapy and rehabilitation

control group

NO INTERVENTION

Interventions

Physical therapy and rehabilitation

connective tissue massage grouplumbal stabilization exercise group

Eligibility Criteria

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

You may qualify if:

  • diagnosed small fiber neuropathy
  • Score-4 and over from the -DN4 score
  • years old adults
  • Volunteers to participate in the study.

You may not qualify if:

  • Pain from different etiologies
  • Other neurological disorders involved in neuropathy evaluation
  • Cognitive or reading disorders to prevent the questionnaires from being filled
  • People with musculoskeletal or orthopedic disorders that affect exercise will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Physical Therapy ModalitiesRehabilitation

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

May 12, 2019

First Posted

May 29, 2019

Study Start

April 18, 2018

Primary Completion

June 5, 2019

Study Completion

June 15, 2019

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations