NCT03702595

Brief Summary

Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Clinical guidelines recommend non-pharmacological conservative treatments for the management of OA. Hip flexors seems to play an important role in the development of hip OA but there is no published studies evaluating the results of a stretching protocol of hip flexors in hip OA patients. The objective of this trial is to evaluate if a stretching protocol of hip flexors is more effective in symptoms, functional capacity , range of motion, strength, muscular length, pain threshold and anxiety and depression compared to control. For this purpose the investigators conduct a single-group, pretest-posttest clinical trial.The investigators included patients diagnosed of hip osteoarthritis Grade I-III by Scale of Kellgren and Lawrence. The variables are measured at the beginning and at the end of treatment of the control phase, and at the end of the stretching protocol phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

August 1, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

August 17, 2018

Last Update Submit

January 17, 2020

Conditions

Keywords

Hip OsteoarthritisManual therapyphysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in pain intensity

    Visual Analogic Scale

    3 weeks

Secondary Outcomes (7)

  • Functional Capacity

    3 weeks

  • WOMAC questionnaire

    3 weeks

  • Hip Range of Motion

    3 weeks

  • Muscular strength

    3 weeks

  • Muscular length

    3 weeks

  • +2 more secondary outcomes

Study Arms (1)

Interventional group

EXPERIMENTAL

Hip flexors stretching protocol

Other: Hip flexors stretching protocol

Interventions

Stretching protocol of rectus femoris, vastus lateralis and iliopsoas according to Kaltenborn- Evjenth Orthopaedic Manual Therapy Concept (OMT)

Interventional group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed medically with a X-Ray test
  • American College of Rheumatology Criteria

You may not qualify if:

  • Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
  • Vascular or neurological disease.
  • Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
  • Grade IV in Kellgren and Laurence Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sandra Jiménez del Barrio

Soria, 42004, Spain

Location

Luis Ceballos Laita

Zaragoza, 50008, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2018

First Posted

October 11, 2018

Study Start

August 1, 2018

Primary Completion

November 30, 2018

Study Completion

December 30, 2018

Last Updated

January 21, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

The patient data were confidential and were assigned a number to each patient to maintain confidentiality

Locations