Exploration of Gait Biomechanics and Pain

NCT ID: NCT06330402

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2025-09-01

Brief Summary

This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:

• How do gait patterns change during painful walking?
• Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?

Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition).

Detailed Description

This study will be a randomized, crossover design where experimental knee pain will be provoked in healthy subjects using hypertonic saline injections to the infrapatellar fat pad (IFP). This will be controlled with a second injection of isotonic saline, which is non-painful. The participants will not be informed of the type of injection.

Hypertonic saline injections to the IFP usually provoke pain lasting about 15 minutes. Within this timeframe, motion capture will be conducted to estimate the biomechanics of gait. During the motion capture the participants will perform five 10-meter walking trials and three jumps. This process will be replicated for the control condition.

Additionally, the participants will have their pain sensitivity tested using cuff-pressure algometry before both IFP injections.

Conditions

Pain; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Painful condition

Hypertonic saline injection to the infrapatellar fat pad.

Group Type: EXPERIMENTAL

Hypertonic saline injection

Intervention Type: OTHER

0.25 mL injection with hypertonic saline (7%) to the infrapatellar fat pad.

Control condition

Isotonic saline injection to the infrapatellar fat pad.

Group Type: PLACEBO_COMPARATOR

Isotonic saline injection

Intervention Type: OTHER

Control injection with 0.25 mL isotonic saline (0.9%) to the infrapatellar fat pad.

Interventions

Hypertonic saline injection

0.25 mL injection with hypertonic saline (7%) to the infrapatellar fat pad.

Intervention Type: OTHER

Isotonic saline injection

Control injection with 0.25 mL isotonic saline (0.9%) to the infrapatellar fat pad.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy men and women aged 18-45 years

Exclusion Criteria

• Pregnancy
• Drug addiction, defined as the use of cannabis, opioids, or other drugs
• Previous or current neurologic or musculoskeletal illnesses
• Current pain
• Lack of ability to cooperate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kristian Kjær Petersen

OTHER

Sponsor Role: lead

Responsible Party

Kristian Kjær Petersen

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Aalborg University

Aalborg, North Denmark, Denmark

Countries

Denmark

Other Identifiers

N-20220063

Identifier Type: -

Identifier Source: org_study_id