Trial Outcomes & Findings for Plantar Heel Pain: Multisegment Foot Motion and Muscle Function, FFI Translation, and Evaluation of Treatments (NCT NCT03161314)

NCT ID: NCT03161314

Last Updated: 2025-07-04

Results Overview

Worst pain was assessed using the Visual analog scale (VAS), where 0 indicates "no pain" and 10 indicates "pain as bad as participants can imagine". Participants were asked to report their worst pain level over the past 24 hours. Higher scores indicate more severe pain. Unit of Measure: scores

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up
• Results posted on: 2025-07-04

Participant Flow

Conducted at Physical Therapy Center, Mahidol University (study 3)

Participant milestones

Measure	Strengthening Group Conservative physical therapy with home-based strengthening exercises (study 3)	Stretching Group conservative physical therapy with home-based stretching exercises (study 3)
Baseline STARTED	42	42
Baseline COMPLETED	42	42
Baseline NOT COMPLETED	0	0
2 Weeks After the Intervention STARTED	42	42
2 Weeks After the Intervention COMPLETED	42	42
2 Weeks After the Intervention NOT COMPLETED	0	0
4 Weeks After the Intervention STARTED	42	42
4 Weeks After the Intervention COMPLETED	42	42
4 Weeks After the Intervention NOT COMPLETED	0	0
1-month Follow-up STARTED	42	42
1-month Follow-up COMPLETED	42	42
1-month Follow-up NOT COMPLETED	0	0
2-month Follow-up STARTED	42	42
2-month Follow-up COMPLETED	42	42
2-month Follow-up NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Strengthening Group n=42 Participants Conservative physical therapy with home-based strengthening exercises	Stretching Group n=42 Participants Conservative physical therapy with home-based stretching exercises	Total n=84 Participants Total of all reporting groups
Age, Continuous	51.95 years STANDARD_DEVIATION 10.10 • n=42 Participants	52.86 years STANDARD_DEVIATION 9.84 • n=42 Participants	52.40 years STANDARD_DEVIATION 9.97 • n=84 Participants
Sex: Female, Male Female	29 Participants n=42 Participants	33 Participants n=42 Participants	62 Participants n=84 Participants
Sex: Female, Male Male	13 Participants n=42 Participants	9 Participants n=42 Participants	22 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Weight	65.66 kg STANDARD_DEVIATION 11.26 • n=42 Participants	65.14 kg STANDARD_DEVIATION 12.52 • n=42 Participants	65.40 kg STANDARD_DEVIATION 11.90 • n=84 Participants
Height	161.13 cm STANDARD_DEVIATION 9.18 • n=42 Participants	159.45 cm STANDARD_DEVIATION 8.13 • n=42 Participants	160.05 cm STANDARD_DEVIATION 8.67 • n=84 Participants
Pain at worst intensity	5.96 scores STANDARD_DEVIATION 2.3 • n=42 Participants	5.74 scores STANDARD_DEVIATION 2.3 • n=42 Participants	5.85 scores STANDARD_DEVIATION 2.3 • n=84 Participants

PRIMARY outcome

Timeframe: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

Worst pain was assessed using the Visual analog scale (VAS), where 0 indicates "no pain" and 10 indicates "pain as bad as participants can imagine". Participants were asked to report their worst pain level over the past 24 hours. Higher scores indicate more severe pain. Unit of Measure: scores

Outcome measures

Measure	Strengthening Group n=42 Participants Conservative physical therapy with home-based strengthening exercises (study 3)	Stretching Group n=42 Participants conservative physical therapy with home-based stretching exercises (study 3)
Worst Pain Baseline	5.96 score Standard Deviation 2.3	5.74 score Standard Deviation 2.3
Worst Pain 2 weeks after the intervention	3.91 score Standard Deviation 2.38	4.08 score Standard Deviation 2.29
Worst Pain 4 weeks after the intervention	3.09 score Standard Deviation 2.25	3.34 score Standard Deviation 2.47
Worst Pain 1-month follow-up	2.52 score Standard Deviation 2.55	2.69 score Standard Deviation 2.55
Worst Pain 2-month follow-up	1.73 score Standard Deviation 2.16	2.69 score Standard Deviation 2.55

PRIMARY outcome

Timeframe: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

Morning pain intensity upon waking was assessed using a 10 cm Visual Analog Scale (VAS), where participants mark a point along a continuous line anchored by "no pain" (0) and "worst imaginable pain" (10), with higher values indicating more severe morning pain. Unit of Measure: scores

Outcome measures

Measure	Strengthening Group n=42 Participants Conservative physical therapy with home-based strengthening exercises (study 3)	Stretching Group n=42 Participants conservative physical therapy with home-based stretching exercises (study 3)
Morning Pain Baseline	5.86 score Standard Deviation 2.51	5.04 score Standard Deviation 2.35
Morning Pain 2 weeks after the intervention	3.70 score Standard Deviation 2.28	3.63 score Standard Deviation 2.54
Morning Pain 4 weeks after the intervention	2.90 score Standard Deviation 2.46	2.75 score Standard Deviation 2.52
Morning Pain 1-month follow-up	2.25 score Standard Deviation 2.51	1.98 score Standard Deviation 2.24
Morning Pain 2-month follow-up	1.30 score Standard Deviation 1.54	1.52 score Standard Deviation 2.12

SECONDARY outcome

Timeframe: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

Cadence refers to the number of steps taken per minute during walking. It is a critical parameter in gait analysis, influencing both performance and injury risk, and the effectiveness of rehabilitation programs. Unit of Measure: steps/minute

Outcome measures

Measure	Strengthening Group n=42 Participants Conservative physical therapy with home-based strengthening exercises (study 3)	Stretching Group n=42 Participants conservative physical therapy with home-based stretching exercises (study 3)
Cadence Baseline	103.16 steps/minute Standard Deviation 7.75	101.37 steps/minute Standard Deviation 10.44
Cadence 2 weeks after the intervention	102.85 steps/minute Standard Deviation 8.54	103.70 steps/minute Standard Deviation 9.82
Cadence 4 weeks after the intervention	104.03 steps/minute Standard Deviation 8.42	103.46 steps/minute Standard Deviation 10.42
Cadence 1-month follow-up	104.72 steps/minute Standard Deviation 8.45	104.16 steps/minute Standard Deviation 9.35
Cadence 2-month follow-up	105.50 steps/minute Standard Deviation 8.47	104.81 steps/minute Standard Deviation 9.49

SECONDARY outcome

Timeframe: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

Stride length is the distance covered between two consecutive placements of the same foot during walking. It represents the length of a full gait cycle, encompassing both the stance and swing phases of the same limb. In clinical assessments, stride length is measured to evaluate gait efficiency, balance, and the effectiveness of rehabilitation program. Unit of Measure: meter

Outcome measures

Measure	Strengthening Group n=42 Participants Conservative physical therapy with home-based strengthening exercises (study 3)	Stretching Group n=42 Participants conservative physical therapy with home-based stretching exercises (study 3)
Stride Length Baseline	1.05 meter Standard Deviation 0.11	1.03 meter Standard Deviation 0.10
Stride Length 2 weeks after the intervention	1.06 meter Standard Deviation 0.10	1.06 meter Standard Deviation 0.10
Stride Length 4 weeks after the intervention	1.05 meter Standard Deviation 0.10	1.05 meter Standard Deviation 0.10
Stride Length 1-month follow-up	1.07 meter Standard Deviation 0.09	1.07 meter Standard Deviation 0.11
Stride Length 2-month follow-up	1.07 meter Standard Deviation 0.10	1.08 meter Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

Time spend during walking over one gait cycle (s)

Stride time refers to the duration of one full gait cycle, measured from the initial contact of one foot to the subsequent initial contact of the same foot. It encompasses both the stance and swing phases of the limb's movement. Stride time is a critical temporal parameter in gait analysis, providing insights into the rhythm and coordination of walking. Unit of Measure: second

Outcome measures

Measure	Strengthening Group n=42 Participants Conservative physical therapy with home-based strengthening exercises (study 3)	Stretching Group n=42 Participants conservative physical therapy with home-based stretching exercises (study 3)
Stride Time 2-month follow-up	1.14 second Standard Deviation 0.10	1.15 second Standard Deviation 0.11
Stride Time Baseline	1.17 second Standard Deviation 0.09	1.19 second Standard Deviation 0.13
Stride Time 2 weeks after the intervention	1.17 second Standard Deviation 0.10	1.16 second Standard Deviation 0.12
Stride Time 4 weeks after the intervention	1.15 second Standard Deviation 0.10	1.17 second Standard Deviation 0.13
Stride Time 1-month follow-up	1.15 second Standard Deviation 0.10	1.16 second Standard Deviation 0.11

SECONDARY outcome

Timeframe: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

Distance of walking over time (m/s)

Gait speed refers to the rate at which an individual walks. It serves as a crucial indicator of mobility and overall physical fitness, playing a significant role in assessing an individual's balance, endurance, and functional abilities. Unit of Measure: meter/second

Outcome measures

Measure	Strengthening Group n=42 Participants Conservative physical therapy with home-based strengthening exercises (study 3)	Stretching Group n=42 Participants conservative physical therapy with home-based stretching exercises (study 3)
Gait Speed Baseline	0.90 meter/second Standard Deviation 0.11	0.87 meter/second Standard Deviation 0.13
Gait Speed 2 weeks after the intervention	0.91 meter/second Standard Deviation 0.12	0.91 meter/second Standard Deviation 0.13
Gait Speed 4 weeks after the intervention	0.92 meter/second Standard Deviation 0.12	0.91 meter/second Standard Deviation 0.13
Gait Speed 1-month follow-up	0.93 meter/second Standard Deviation 0.12	0.93 meter/second Standard Deviation 0.13
Gait Speed 2-month follow-up	0.94 meter/second Standard Deviation 0.12	0.94 meter/second Standard Deviation 0.13

Adverse Events

Strengthening Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stretching Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Asst.Prof.Dr. Sunee Bovonsunthonchai

Physical Therapy Faculty, Mahidol University

Phone: 024415450

Email: sunee.bov@mahidol.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place